Testimonials

All

FDA 483 and Warning Letter Resolution

Quality Systems

GMP Training

FDA Submissions

Internal Audits

Design Controls / Product Development

Canadian Licensing

General

"...Clone Kevin Randall."

– President & CEO, Class II device Manufacturer, ,

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“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”

– CEO – Class II device Manufacturer, ,

|
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection… “

– Operations Director – Class III device Manufacturer & Distributor, ,

|
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”

– Director, Regulatory Affairs & Quality Assurance, Class II devices, ,

|
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

– President & CEO – Class II device Manufacturer, ,

|
“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”

– Quality Manager, Class II devices, ,

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"...Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole..."

– COO – Class II device Manufacturer, ,

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“…Kevin committed himself to understanding our business model, products and processes before tailoring training and compliance solutions for our firm. This has been greatly beneficial to our firm from an economic and time perspective as it has built on our systems and processes rather than starting again…”

A GMP training attendee, ,

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“…Kevin was very engaging throughout the presentations. His content was well presented, and the slides coincided with the presentation. Overall, I learned a lot from this program…”

A GMP training attendee, ,

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“…Kevin's interaction and communication is always respectful and clear. He has demonstrated an ability to explain concepts in a manner which is applicable to the audience…”

A GMP training attendee, ,

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"...I would describe your training in design controls to be the foundation of my current understanding of agency requirements. You were the first company I worked with to take the time to dredge through the details. Something I badly needed to complete the picture of developing a design control, and product launch framework..."

– Director of Development and Manufacturing Operations, ,

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“…ComplianceAcuity is the 4th regulatory consultant I have used over the years. By far he has been head and shoulders above the others for the following reasons: 1) Expertise with regulations. Others did not have the breadth and depth of his expertise. 2) Quality of his solutions and ability to tailor to our firm as opposed to other consultants who used 'template-based' solutions. 3) Kevin himself is highly intelligent which enables him to quickly understand our products and processes to enable him to provide appropriate solutions the first time. This is a rare ability. 4) His personal commitment to our company was as high as any of our or our own employees. For example, he made various personal sacrifices to ensure our firm was as best prepared as possible for our recent FDA audit…”

– Director, Regulatory Affairs & Quality Assurance, Class II device Manufacturer, ,

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"...You were able to help me manage the QA and Regulatory functions prior to hirng our own staff. This worked very well. You interfaced well with our engineerng staff in addressing our most important Quality Management System issues..."

– President and CEO, Class II device Manufacturer, ,

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“…Well, [Kevin Randall] is the word smith master. His knowledge of QS regs, principles and processes is exceptional and is able to promptly provide solutions...”

– Quality Manager, ,

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“…Kevin’s pace and speaking style brought life to the regulations…”

A GMP training attendee, ,

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“…Kevin Randall did an excellent job elaborating on the slides, stating not only the FDA regulations,but also the real world expectations for the regulations…”

A GMP training attendee, ,

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“…I really appreciated how examples of the Preamble were often cited, as the FDA also cited the importance of them in their training…”

A GMP training attendee, ,

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“…Kevin – Loved your passion and thorough understanding. Good presentation – clear and articulate…”

A GMP training attendee, ,

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“…Training was very good for the whole team, and being able to be present and attend to specific requests was most valuable. Working through all the issues identified, Kevin was able to propose and guide through many solutions…”

A GMP Training Attendees, ,

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“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

– Director of Operations – Class II and III device Manufacturer, ,

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"...One of the areas in my work to develop company systems with ComplianceAcuity I found most useful was to build a system and then review it with you in detail. This was a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."

– Director of Development and Manufacturing Operations – Class II device Manufacturer, ,

|
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

– President, Class II devices, ,

|
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

– Sr. Process & Quality Manager, ,

|
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”

– Director of Operations, Class III devices, ,

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“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”

– VP Regulatory and Scientific Affairs, Class III devices, ,

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“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort...”

– Sr. QA Manager, Design & Development, ,

|
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

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"...Highly professional and very detail oriented...Of all the suppliers I have used over the years, ComplianceAcuity earned my highest recommendation..."

– COO, Class II device Manufacturer, ,

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"...Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS..."

– President & CEO, Class II device Manufacturer, ,

|
“…ComplianceAcuity is the 4th regulatory consultant I have used over the years. By far he has been head and shoulders above the others for the following reasons: 1) Expertise with regulations. Others did not have the breadth and depth of his expertise. 2) Quality of his solutions and ability to tailor to our firm as opposed to other consultants who used 'template-based' solutions. 3) Kevin himself is highly intelligent which enables him to quickly understand our products and processes to enable him to provide appropriate solutions the first time. This is a rare ability. 4) His personal commitment to our company was as high as any of our or our own employees. For example, he made various personal sacrifices to ensure our firm was as best prepared as possible for our recent FDA audit…”

– Director, Regulatory Affairs & Quality Assurance, Class II device Manufacturer, ,

|
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance…”

– CEO – Class II device Manufacturer, ,

|
“…Well, [Kevin Randall] is the word smith master. His knowledge of QS regs, principles and processes is exceptional and is able to promptly provide solutions...”

– Quality Manager, ,

|
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

– President & Founder – Virtual Manufacturer of Class II devices, ,

|
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection…“

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…The bottom line is that, due to ComplianceAcuity's efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his Associates...”

– CEO – Class II device Manufacturer, ,

|
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had now been recognized as being completely addressed....”

– Director, Regulatory Affairs & Quality Assurance, Class II devices, ,

|
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."

– President & CEO – Class II device Manufacturer, ,

|
“…Definitely added value. With the gap audit, ComplianceAcuity found many crucial gaps and helped provide high level solutions to fill the gaps. Without the expertise of ComplianceAcuity our last FDA audit would have been a disaster...”

– Quality Manager, Class II devices, ,

|
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of whom was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection...“

Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”

– CEO – Class II device Manufacturer, ,

|
"... a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor before they are asked..."

– COO – Class II device Manufacturer, ,

|
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”

– Customer Service Supervisor – Class II & III device Manufacturer, ,

|
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business…”

– Operations Director – Class III device Manufacturer & Distributor, ,

|
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”

– CEO – Class II device Manufacturer, ,

|
“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

– President & Founder – Virtual Manufacturer of Class II devices, ,

|
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity taught us how to understand and speak FDA’s language...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…The systems you delivered are highly customized to meet our compliance requirements and business needs. All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover: 1. Compliance and regulatory understanding, was/is not wide-spread. 2. Having the skill sets and time to create Policies/Procedures/Work Instructions. Having [ComplianceAcuity’s] regulatory expertise combined with the documentation skills added immense value since we were trying to run the current system while creating a new one. You certainly brought a high level of expertise and professionalism, mixed with enough humor to keep us all sane!”

– 12-year veteran in various positions including Director of Quality, ,

|
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”

– Director of Quality – Class II & III device Manufacturer, ,

|
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

– Sr. Process & Quality Manager, ,

|
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”

– Senior Process and Quality Manager – Class I device Manufacturer, ,

|
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

– Sr. QA Manager, Design & Development, ,

|
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”

– QA Manager – Class II device Manufacturer, ,

|
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”

– President – Class II & III device Manufacturer, ,

|
“…We were quite impressed with your abilities...”

– QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices, ,

|
“…I appreciate all the assistance you have provided and look forward to working with you in the future...”

– Business Development – Class II device Virtual Manufacturer, ,

|
“…ComplianceAcuity ensured that our best interests were always priority #1...”

– QA Manager – Class II device Manufacturer, ,

|
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”

– Sr. Quality Engineer – Class II & III device Manufacturer, ,

|
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort...”

– Sr. QA Manager, Design & Development, ,

|
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

– Sr. Process & Quality Manager, ,

|
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused…”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”

– Senior Process and Quality Manager, ,

|
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business…”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

– Sr. QA Manager, Design & Development, ,

|
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”

– QA Manager – Class II device Manufacturer, ,

|
“…The systems you delivered are highly customized to meet our compliance requirements and business needs. All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover: 1. Compliance and regulatory understanding, was/is not wide-spread. 2. Having the skill sets and time to create Policies/Procedures/Work Instructions. Having [ComplianceAcuity’s] regulatory expertise combined with the documentation skills added immense value since we were trying to run the current system while creating a new one. You certainly brought a high level of expertise and professionalism, mixed with enough humor to keep us all sane!”

– 12-year veteran in various positions including Director of Quality, ,

|
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO…”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”

– President – Class II & III device Manufacturer, ,

|
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues…”

– Sr. QA Manager, Design & Development, ,

|
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”

– Director of Quality – Class II & III device Manufacturer, ,

|
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts...”

– Director of Operations – Class II and III device Manufacturer, ,

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“…We were very pleased with Kevin's work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company's procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and timely. He was very professional in his dealing with our audit area management teams. We would use Kevin again if needed...”

– Manager, Quality Systems – Class II & III device Manufacturer, ,

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“…A lasting benefit of having ComplianceAcuity conduct an internal audit was the creation of a professional relationship upon which our company can depend for informed, top-quality consulting services when we are faced with an issue beyond the scope of our internal quality personnel’s experiences...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

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“…with ComplianceAcuity’s track record and thorough understanding of the Design Control regulations…I can fully recommend Kevin’s capable services. I would be happy to have Kevin back...”

– Sr. QA Manager, Design & Development, ,

|
“…You took a lot of your time to mentor me. I am a more knowledgeable person for it…”

– QA Manager – Class II device Manufacturer, ,

|
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…The bottom line is that, due to ComplianceAcuity’s efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his ComplianceAcuity Associates…”

– CEO – Class II device Manufacturer, ,

|
“…We were quite impressed with your abilities...”

– QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices, ,

|
“…We were very satisfied with the results. You provided a template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient…”

– Customer Service Supervisor – Class II & III device Manufacturer, ,

|
“…ComplianceAcuity taught us how to understand and speak FDA’s language…”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings…”

– CEO – Class II device Manufacturer, ,

|
“…I appreciate all the assistance you have provided and look forward to working with you in the future...”

– Business Development – Class II device Virtual Manufacturer, ,

|
“…ComplianceAcuity ensured that our best interests were always priority #1...”

– QA Manager – Class II device Manufacturer, ,

|
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with…”

– Sr. Quality Engineer – Class II & III device Manufacturer, ,

|
“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line…”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Kevin has the knowledge and experience to provide excellent regulatory guidance. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects…”

– QA Manager – Class II and III device Manufacturer, ,

|
“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly…”

– Sr. QA Manager, Design & Development, ,

|
“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

– Director of Operations – Class II and III device Manufacturer, ,

|
"...The most significant contribution [by ComplianceAcuity] was managing the interface with the FDA to obtain the clearance with a challenging set of circumstances..."

– President & CEO, Class II device Manufacturer, ,

|
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction...”

– CEO – Class II device Manufacturer, ,

|
“…ComplianceAcuity promised to ensure we would obtain our 510K approval on time. Instead they delivered well ahead of the standard review duration, in fact 30% ahead of the standard FDA timeline, enabling our company to enter our product to market well ahead of schedule....”

– QA Manager – Class II device Manufacturer, ,

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"...Kevin Randall is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will be well-served to have a conversation with Kevin Randall..."

– Sr Process and Quality Manager – Class II device Manufacturer, ,

|
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

– President & Founder – Virtual Manufacturer of Class II devices, ,

|
“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity’s capabilities in managing the FDA review process are strong. Kevin would keep us updated at all times during his interaction with the FDA as our representative. He would ensure that we completely understood what we were up against. If we had an issue with some of the FDA requests, ComplianceAcuity would go to bat to ensure FDA understood our request to dispute certain requests and vice versa (helping us understand the FDA requirements)...”

– QA Manager – Class II device Manufacturer, ,

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“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional...”

– QA Manager – Class II device Manufacturer, ,

|
“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it submitted and reviewed promptly. When FDA had a request for additional documentation, you were able to provide a template for our Patient Instruction booklet that allowed us to complete the content efficiently...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…As QA Manager I have had several opportunities to work with ComplianceAcuity, specifically, Kevin Randall and 510K submissions. Kevin has the knowledge and experience to provide excellent regulatory guidance. His knowledge of FDA regulations enabled Kevin to write, submit and receive approval for our 510k from the FDA promptly and without issue. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects...”

– QA Manager – Class II and III device Manufacturer, ,

|
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”

– QA Manager – Class II device Manufacturer, ,

|
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity ensured that our best interests were always priority #1...”

– QA Manager – Class II device Manufacturer, ,

|
“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line.”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…Thanks! ComplianceAcuity’s internal audit SOP is much higher quality than what we had in our current QMS...”

– Sr. Process & Quality Manager, ,

|
“…We were very pleased with Kevin's work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company's procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and timely. He was very professional in his dealing with our audit area management teams. We would use Kevin again if needed...”

– Manager, Quality Systems – Class II & III device Manufacturer, ,

|
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services we were better prepared and achieved a positive outcome when FDA performed a follow-up inspection...“

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment...”

– Senior Process and Quality Manager – Class I device Manufacturer, ,

|
“…Kevin was very diligent and rigorous in his processing work for the Complaint Handling and CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”

– Director of Quality – Class II & III device Manufacturer, ,

|
“…A lasting benefit of having ComplianceAcuity conduct an internal audit was the creation of a professional relationship upon which our company can depend for informed, top-quality consulting services when we are faced with an issue beyond the scope of our internal quality personnel’s experiences...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts.”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our business...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”

– CEO – Class II device Manufacturer, ,

|
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

– President & Founder – Virtual Manufacturer of Class II devices, ,

|
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places…”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…The bottom line is that, due to ComplianceAcuity’s efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his ComplianceAcuity Associates...”

– CEO – Class II device Manufacturer, ,

|
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings...”

– CEO – Class II device Manufacturer, ,

|
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”

– Sr. Quality Engineer – Class II & III device Manufacturer, ,

|
“…The systems you delivered are highly customized to meet our compliance requirements and business needs. All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover: 1. Compliance and regulatory understanding, was/is not wide-spread. 2. Having the skill sets and time to create Policies/Procedures/Work Instructions. Having [ComplianceAcuity’s] regulatory expertise combined with the documentation skills added immense value since we were trying to run the current system while creating a new one. You certainly brought a high level of expertise and professionalism, mixed with enough humor to keep us all sane!”

– 12-year veteran in various positions including Director of Quality, ,

|
“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient...”

– Customer Service Supervisor – Class II & III device Manufacturer, ,

|
“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity taught us how to understand and speak FDA’s language...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

– Sr. QA Manager, Design & Development, ,

|
“…You provided a [design input] template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”

– Director of Operations – Class II and III device Manufacturer, ,

|
"...I would describe your training in designe controls to be the foundation of my current understanding of agency requiremets. You were the first company I worked with to take the time to dredge through the details. Something I badly needed to complete the picture of developing a design control, and product launch framework."

– Director Development and Manufacturing Operations – Class II device Manufacturer, ,

|
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

– President & Founder – Virtual Manufacturer of Class II devices, ,

|
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort...”

– Sr. QA Manager, Design & Development, ,

|
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”

– CEO – Class II device Manufacturer, ,

|
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues...”

– Sr. QA Manager, Design & Development, ,

|
“…Kevin responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”

– Director of Quality – Class II & III device Manufacturer, ,

|
“…with ComplianceAcuity’s track record and thorough understanding of the Design Control regulations…I can fully recommend Kevin’s capable services. I would be happy to have Kevin back...”

– Sr. QA Manager, Design & Development, ,

|
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”

– QA Manager – Class II device Manufacturer, ,

|
“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly...”

– Sr. QA Manager, Design & Development, ,

|
“…We were quite impressed with your abilities...”

– QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices, ,

|
“…The bottom line is that, due to ComplianceAcuity’s efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his ComplianceAcuity Associates…”

– CEO – Class II device Manufacturer, ,

|
“…You took a lot of your time to mentor me. I am a more knowledgeable person for it...”

– QA Manager – Class II device Manufacturer, ,

|
“…The biggest value ComplianceAcuity brought to the table for us was communication…ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project…”

– CEO – Class II device Manufacturer, ,

|
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with...”

– Sr. Quality Engineer – Class II & III device Manufacturer, ,

|
“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient…”

– Customer Service Supervisor – Class II & III device Manufacturer, ,

|
“…Kevin has the knowledge and experience to provide excellent regulatory guidance…His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects...”

– QA Manager – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects…I strongly recommend the services of ComplianceAcuity, and will use them again…”

– President – Class II&III device Manufacturer, ,

|
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”

– VP Regulatory and Scientific Affairs, ,

|
"...Kevin Randall is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will be well-served to have a conversation with Kevin Randall..."

– Sr Process and Quality Manager – Class II device Manufacturer, ,

|
“…Kevin has the knowledge and experience to provide excellent regulatory guidance. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects...”

– QA Manager – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional…”

– QA Manager – Class II device Manufacturer, ,

|
“…Like many companies, we know “our business” but the intricacies of developing, implementing, and maintaining an effective medical device quality system was beyond our expertise (as illustrated by our recent inspection) and it was too late to gain traction on the project alone. Kevin and his Associates at ComplianceAcuity from day one had a unique ability to pull conflicting parties together within our organization. ComplianceAcuity defined the scope of the problems at hand, compartmentalized the project into understandable components, developed a realistic game plan, and worked one-on-one with our staff to bring our organization into compliance...”

– CEO – Class II device Manufacturer, ,

|
“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Kevin's work style was logical and well-thought out making him easy to work with. The project turned out better than expected. Kevin is able to explain complex issues in an easy to understand way...”

– President & Founder – Virtual Manufacturer of Class II devices, ,

|
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from…”

– Sr. Process & Quality Manager, ,

|
“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”

– QA Manager – Class II device Manufacturer, ,

|
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

– Director of Operations – Class II and III device Manufacturer, ,

|
"...Kevin Randall is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will be well-served to have a conversation with Kevin Randall..."

– Sr Process and Quality Manager – Class II device Manufacturer, ,

|
"...You were able to integrate with company staff and work alongside them as if an employee and thus were able to complete the tasks while simultaneously achieve acceptance by internal staff and employees..."

– President & CEO, Class II device Manufactuer, ,

|
“…Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly supports our goals to grow our business...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance...”

– Sr. QA Manager, Design & Development, ,

|
“…The systems you delivered are highly customized to meet our compliance requirements and business needs. All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover: 1. Compliance and regulatory understanding, was/is not wide-spread. 2. Having the skill sets and time to create Policies/Procedures/Work Instructions. Having [ComplianceAcuity’s] regulatory expertise combined with the documentation skills added immense value since we were trying to run the current system while creating a new one. You certainly brought a high level of expertise and professionalism, mixed with enough humor to keep us all sane!”

– 12-year veteran in various positions including Director of Quality, ,

|
“…ComplianceAcuity promised to ensure we would obtain our 510K approval on time. Instead they delivered well ahead of the standard review duration, in fact 30% ahead of the standard FDA timeline, enabling our company to enter our product to market well ahead of schedule...”

– QA Manager – Class II device Manufacturer, ,

|
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions...”

– QA Manager – Class II device Manufacturer, ,

|
“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO...”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly recommend the services of ComplianceAcuity, and will use them again...”

– President – Class II&III device Manufacturer, ,

|
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues...”

– Sr. QA Manager, Design & Development, ,

|
“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to "emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It was a pleasure to deal with ComplianceAcuity and would work with them again given the need...”

– Director of Quality – Class II & III device Manufacturer, ,

|
“…ComplianceAcuity’s capabilities in managing the FDA review process are strong. Kevin would keep us updated at all times during his interaction with the FDA as our representative. He would ensure that we completely understood what we were up against. If we had an issue with some of the FDA requests, ComplianceAcuity would go to bat to ensure FDA understood our request to dispute certain requests and vice versa (helping us understand the FDA requirements)...”

– QA Manager – Class II device Manufacturer, ,

|
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts…”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…We were very pleased with Kevin's work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company's procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and timely. He was very professional in his dealing with our audit area management teams. We would use Kevin again if needed…”

– Manager, Quality Systems – Class II & III device Manufacturer, ,

|
“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…A lasting benefit of having ComplianceAcuity conduct an internal audit was the creation of a professional relationship upon which our company can depend for informed, top-quality consulting services when we are faced with an issue beyond the scope of our internal quality personnel’s experiences…”

– Quality Assurance Manager – Class II and III device Manufacturer, ,

|
“…with ComplianceAcuity’s track record and thorough understanding of the Design Control regulations…I can fully recommend Kevin’s capable services. I would be happy to have Kevin back…”

– Sr. QA Manager, Design & Development, ,

|
“…ComplianceAcuity performed our FDA-audit using a process-based approach and provided systematic solutions where needed…”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…You took a lot of your time to mentor me. I am a more knowledgeable person for it...”

– QA Manager – Class II device Manufacturer, ,

|
“…The bottom line is that, due to ComplianceAcuity’s efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I strongly recommend Kevin Randall and his ComplianceAcuity Associates…”

– CEO – Class II device Manufacturer, ,

|
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional…”

– QA Manager – Class II device Manufacturer, ,

|
“…I appreciate all the assistance you have provided and look forward to working with you in the future...”

– Business Development – Class II device Virtual Manufacturer, ,

|
“…We were quite impressed with your abilities...”

– QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices, ,

|
“…We were very satisfied with the results. You provided a template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives. Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions. Assisted tremendously in encapsulating the core issues that needed to be resolved so we could be compliant and still efficient…”

– Customer Service Supervisor – Class II & III device Manufacturer, ,

|
“…ComplianceAcuity taught us how to understand and speak FDA’s language…”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it submitted and reviewed promptly. When FDA had a request for additional documentation, you were able to provide a template for our Patient Instruction booklet that allowed us to complete the content efficiently...”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…The biggest value ComplianceAcuity brought to the table for us was communication. Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking down difficult issues into palatable ones, and educating our personnel without directing blame or allowing interdepartmental conflicts to interfere with the project. In addition, throughout the project I was kept completely informed by detailed progress reports and daily meetings…”

– CEO – Class II device Manufacturer, ,

|
“…We are further along in our business because of ComplianceAcuity’s consulting services. When colleagues ask if I know a good FDA consultant, ComplianceAcuity is the first to come to mind. We will definitely work with ComplianceAcuity again...”

– Director of Operations – Class III device Manufacturer & Distributor, ,

|
“…ComplianceAcuity ensured that our best interests were always priority #1...”

– QA Manager – Class II device Manufacturer, ,

|
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with…”

– Sr. Quality Engineer – Class II & III device Manufacturer, ,

|
“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line…”

– Director of Operations – Class II and III device Manufacturer, ,

|
“…Kevin has the knowledge and experience to provide excellent regulatory guidance. Kevin has also provided regulatory guidance regarding import to foreign countries, guidance in shipping into Canada and has done ISO/FDA audits for our company. His knowledge and attention to detail exceeded my expectations. I look forward to working with Kevin on future projects…”

– QA Manager – Class II and III device Manufacturer, ,

|