“…I do want to thank you again for all your help and expertise. It is nice to have “expert counsel” to learn and help us through our issues…”
– 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…”
– 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…”
– 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…”
– President & Founder – Virtual Manufacturer of 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 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!”
– CEO – Class II device Manufacturer
“…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 […]
– QA Manager – Class II device Manufacturer
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional…”
– 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…”