“…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…”
COO, Class II devices
“…Of all the suppliers I have used over the years ComplianceAcuity earned my highest recommendation…”
GMP Training Attendee
“…Kevin committed himself to understanding our business model, products and processes before tailoring training and compliance solutions for our firm. This has been greatly beneficial to our firm from an economic and time perspective as it has built on our systems and processes rather than starting again…”
COO – Class II device Manufacturer
“…Providing not only the answer, but the reasoning used by regulatory agencies was instrumental not only to our device approval, but to managing the product as a whole…”
Manager, Regulatory Compliance
“…The [EU MDR] importer/distributor assistance was perfect. There were lots of little details that we wouldn’t have grasped without your help. I know that [operations] especially appreciated it….”
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….”
Precision Device Manufacturer
“…Kevin Randall with Compliance Acuity, has been used for the last 3 years of quarterly internal audits. He is reasonable and easy to work with; we plan to continue to use him…”
Chief Operating Officer
“…We really appreciate your work. Looking forward to an EU MDR invoice. As always, thank you for everything…”