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President, Class II & III Devices

“ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in…FDA quality system compliance, training, and auditing.”

– Quality Assurance Manager – 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…”

– Sr. QA Manager, Design & Development

“…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…”

– Director of Operations, Class III devices

“…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 […]

– Sr. Process & Quality Manager

“…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…”

– President, Class II devices

“…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…”

– Director, Regulatory Affairs and Quality Assurance

“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 […]