<h1 class="entry-title">Group: Canadian Licensing</h1>

QA Manager – 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 […]

Sr Process and Quality Manager – Class II 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 […]

QA Manager – 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…”

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. 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…”