Clearly Solving

the Regulatory

Compliance & GMP Puzzle

Compliance and Regulatory Affairs Quality Management Systems (QMS)

™

Sensible customized solutions for sustainable regulatory affairs and quality systems in the medical device and pharma industry

Quality Management Systems (QMS) Testimonials Compliance and Regulatory Affairs

Wondering how your firm could benefit from involving ComplianceAcuity in your business plan?

Welcome to ComplianceAcuity

ComplianceAcuity provides customized, common-sense solutions to achieve sustainable regulatory affairs and quality systems in the medical device and pharma industry. We excel by pairing intelligent business planning with strategic regulatory and quality systems.

Succeeding in today’s dynamic regulatory environment requires that each medical device or pharma business be statutorily fluent yet practical regarding their compliance/regulatory affairs and quality systems.

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Testimonials

"...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 ,

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“…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 ,

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“…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 ,

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"...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 ,

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“…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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“Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation.”

– COO, Class II devices ,

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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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“I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used him.”

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

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“From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to activate a CAPA and how to justify otherwise. This resulted in out team spending time on the highest priority activities (as recognized by regulators) as compared to our previous prioritization which was causing dilution of our efforts.”

– Director, Regulatory Affairs and Quality Assurance ,

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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 ,

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“…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 ,

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“…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 ,

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“…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 ,

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“…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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More Testimonials

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Email Us info@complianceacuity.com

Our Company Golden, CO 80402, USA