“…I would describe your training in design controls to be the foundation of my current understanding of agency requirements. You were the first company I worked with to take the time to dredge through the details. Something I badly needed to complete the picture of developing a design control, and product launch framework.”
<h1 class="entry-title">Group: Design Controls / Product Development</h1>
President – Class II & III device Manufacturer
“…ComplianceAcuity provided extremely valuable consulting to [us] during a very critical time and on critical projects. I witnessed Kevin Randall having particular strengths in these areas: FDA quality system compliance, training, and auditing; Supporting the business objectives of a medical device enterprise; and Due diligence assessments related to acquisitions of medical device enterprises. I strongly […]
Director of Quality – Class II & III device Manufacturer
“…Kevin responded to “emergency” type issues and changed his schedules to accommodate. He helped train people where necessary and tried to explain to people why something was needed as opposed to commanding it in place. He communicated with me often enough that I could make management decisions relative to the systems he was working on…It […]
Director of Operations – Class II and III device Manufacturer
“…You provided a [design input] 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…”
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…”
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…”
Sr. QA Manager, Design & Development
“…Kevin provided positive critique of our Design Control process that has put us in a better compliance footing with external audits going forward. His foundation-building in this arena has helped the management teams become well prepared and will result in fewer compliance issues…”
Sr. QA Manager, Design & Development
“…ComplianceAcuity built a foundation for Design Controls that carry forward to the current time which has made the whole design control effort more sustainable with current head count level. This was chiefly done by mapping the requirements to the final product testing effort…”