“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly…”

“…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…”

“…you are like a partner to our business. When we call for consultation, you always respond to our needs. Either you know the answers or have access to the information. It is important for us to have this type of support and expertise to be able to expand our markets and product line…”

“…I found your knowledge and experience to be top notch.  You were also very easy to communicate and work with…”

“…ComplianceAcuity ensured that our best interests were always priority #1…”

“…We are further along in our business because of ComplianceAcuity’s consulting services.  When colleagues ask if I know a good FDA consultant, ComplianceAcuity is the first to come to mind.  We will definitely work with ComplianceAcuity again…”

“…The biggest value ComplianceAcuity brought to the table for us was communication.  Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking […]

“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it […]

“…ComplianceAcuity taught us how to understand and speak FDA’s language…”

“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives.  Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions.  Assisted tremendously in encapsulating the core issues that needed to be resolved so […]