“…A terrific piece of work, I can see why you have such success with Canadian submissions – Thank You!”
<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 […]
QA Manager – Class II device Manufacturer
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional…”
Director of Operations – 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!”
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…”
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…”
Director of Operations – Class II and III 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…”
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…”