“…Excellent critique was given in the form of design audits that made the design control effort more audit friendly…”
<h1 class="entry-title">Group: Quality Systems</h1>
– 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
“…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…”
– Sr. Quality Engineer – Class II & III device Manufacturer
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with…”
– QA Manager – Class II device Manufacturer
“…ComplianceAcuity ensured that our best interests were always priority #1…”
– Business Development – Class II device Virtual Manufacturer
“…I appreciate all the assistance you have provided and look forward to working with you in the future…”
– CEO – Class II device Manufacturer
“…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 […]
– Director of Operations – Class III device Manufacturer & Distributor
“…ComplianceAcuity taught us how to understand and speak FDA’s language…”
– Customer Service Supervisor – Class II & III device Manufacturer
“…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 […]
– 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…”