“…Thanks again for all your help! I am amazed how quickly you have gotten these submissions through the process!”
<h1 class="entry-title">Archives: Testimonials</h1>
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 device Manufacturer
“…ComplianceAcuity promised to ensure we would obtain our 510K approval on time. Instead they delivered well ahead of the standard review duration, in fact 30% ahead of the standard FDA timeline, enabling our company to enter our product to market well ahead of schedule….”
President & CEO, Class II device Manufacturer
“…The most significant contribution [by ComplianceAcuity] was managing the interface with the FDA to obtain the clearance with a challenging set of circumstances…”
Director of Operations – Class II and III device Manufacturer
“…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 […]
Sr. QA Manager, Design & Development
“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly…”
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…”
Director of Operations – Class II and III device Manufacturer
“…We were very satisfied with the results. You provided a template that assisted us with the Design History File that was useful to organize our activities. You worked in concert with our QA department to keep the process on task and meet our project deadlines…”
QA Manager – Class II device Manufacturer
“…You took a lot of your time to mentor me. I am a more knowledgeable person for it…”
Sr. QA Manager, Design & Development
“…with ComplianceAcuity’s track record and thorough understanding of the Design Control regulations…I can fully recommend Kevin’s capable services. I would be happy to have Kevin back…”