“…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 […]
<h1 class="entry-title">Group: Compliance & Regulatory Affairs</h1>
QA Manager – Class II and III device Manufacturer
“…As QA Manager I have had several opportunities to work with ComplianceAcuity, specifically, Kevin Randall and 510K submissions. Kevin has the knowledge and experience to provide excellent regulatory guidance. His knowledge of FDA regulations enabled Kevin to write, submit and receive approval for our 510k from the FDA promptly and without issue. Kevin has also […]
QA Manager – Class II device Manufacturer
“…ComplianceAcuity’s finished submission product (content and hard copy appearance) was very professional…”
Sr Process and Quality Manager – Class II device Manufacturer
“…Kevin Randall is the consummate professional who goes above and beyond when the situation warrants. What I appreciated most about his expertise is that he can teach without lording it over you. If you are looking for an external consultant to help with those complex FDA, Health Canada, and/or European Commission regulatory issues, you will […]
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, Regulatory Affairs and Quality Assurance
“…From my experience with ComplianceAcuity, I have always observed the highest level of expertise in delivering tailored and practical compliance solutions. For example, Kevin was able to help us remodel our CAPA and data monitoring processes which resulted in a very high level of confidence in our ability to clearly identify when we needed to […]
Director, Regulatory Affairs and Quality Assurance, Class II devices
“…I will continue to use ComplianceAcuity for our regulatory and quality needs. We have had successful outcomes each time we have used ComplianceAcuity…”
President and CEO, Class II device Manufacturer
“…You were able to help me manage the QA and Regulatory functions prior to hiring our own staff. This worked very well. You interfaced well with our engineering staff in addressing our most important Quality Management System issues…”
President, Chief Engineer – Software Device
“…Thanks! This [EU MDR Clinical Evaluation Plan] looks very good…”
Regulatory Compliance Manager
“…The EU MDR SOPs were great and much appreciated. With all the labeling work that I had to do, it would have been very easy for me to just overlook the SOPs or to make them so generic that they wouldn’t be useful….”