“…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 […]
<h1 class="entry-title">Group: Quality Systems</h1>
Office Manager – Class II Software Device
“…Thank you Kevin – [The complaint handling training] was extremely helpful for me…”
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…”
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…”
Quality Assurance Manager – Class II and III device Manufacturer
“…A lasting benefit of having ComplianceAcuity conduct an internal audit was the creation of a professional relationship upon which our company can depend for informed, top-quality consulting services when we are faced with an issue beyond the scope of our internal quality personnel’s experiences…”