Kevin Randall is Principal Consultant at ComplianceAcuity. Be sure to visit his LinkedIn page.
Since entering the profession in 1995, Kevin has continuously contributed to the business goals of medical device companies ranging from small start-ups to large international enterprises.
- 20+ years building sustainable quality systems and compliance operations.
- Distinguished mix of hands-on technical skills and astute management used to devise and implement intelligent strategic plans yielding superior outcomes.
- Acclaimed quality systems instructor.
- Outstanding aptitude for reforming ineffective regulated operations to achieve gold-standard compliance and output in quality systems and regulatory affairs. Track record of delivering creative and sensible solutions assuring customer needs are met while promoting business growth and profitability. Client feedback confirms that Kevin excels by combining intelligent business planning with proven regulatory and quality system strategy.
- Kevin holds two science degrees, has authored articles, taught at local and national conferences, is an ASQ Certified Quality Auditor, and holds RAPS Regulatory Affairs Certifications (RAC) for the U.S., Europe, and Canada.
- Supported where needed by an elite team of globally-certified regulatory, clinical, and quality system professionals whose proven commitment and credentials ensure that each new client realizes the same value reflected in our client testimonials.
- Highly customized systems that meet your business needs
- Proven expertise and support to expand your markets and products
- Faster market launches
- Global regulatory expertise to meet your worldwide business goals
- Complex projects made manageable
- Realistic game plans and tactics
- Effective resolution of longstanding compliance problems
- Diplomatic problem-solving instead of forced solutions
- Harmonization of conflicting parties in your organization
- Your best interests are always the first priority
- Logical, well-thought out style that is easy to work with
- Complex issues explained in an easy to understand way
- Diligent and rigorous processing of assignments
- Timely responsiveness
- Routine communication that facilitates your management decisions
- Schedules adjusted to address “emergency” issues
- Personal, patient approach
- Careful attention to your questions, followed by clear, reliable answers
- Strategic counsel that adds value to your business
- Business relationships based on a high level of integrity
- Experienced, tactful interface with your personnel
“…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...”
"...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..."
"...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..."
“…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...”
“…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...”
“…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…”
“…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....”
“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.”
“I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used him.”
“…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… “
"...We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance..."
“…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...”
“…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…”
“…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...”
“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”
“…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…”