“…We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance…”
<h1 class="entry-title">Group: Home</h1>
Director, Regulatory Affairs & Quality Assurance, Class II devices
“…ComplianceAcuity has added considerable value to our company by helping us understand any gaps in our compliance to FDA QS Regulations. Additionally, ComplianceAcuity was able to help us implement practical solutions to bring us in line with best practice. This was demonstrated by our recent FDA audit where previous issues identified by the FDA had […]
Director of Operations – Class III device Manufacturer & Distributor
“…After a series of unsuccessful FDA inspections resulting in a Warning Letter, ComplianceAcuity was hired to help resolve our longstanding issues. ComplianceAcuity clarified the problems and provided professional solutions where prior consultants, one of which was an “ex-FDAer”, did not. Because of ComplianceAcuity’s services, we were better prepared and achieved a positive outcome when FDA […]
Quality Manager
“…Well, [Kevin Randall] is the word smith master. His knowledge of QS regs, principles and processes is exceptional and is able to promptly provide solutions…”
Director, Regulatory Affairs & Quality Assurance, Class II device Manufacturer
“…ComplianceAcuity is the 4th regulatory consultant I have used over the years. By far he has been head and shoulders above the others for the following reasons: 1) Expertise with regulations. Others did not have the breadth and depth of his expertise. 2) Quality of his solutions and ability to tailor to our firm as […]
President & CEO, Class II device Manufacturer
“…Your services were customized to the specific needs and constraints of our company instead of providing a canned process that did not fit our business model or intended QMS…We would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS…”
Director of Development and Manufacturing Operations – Class II device Manufacturer
“…One of the areas in my work to develop company systems with ComplianceAcuity I found most useful was to build a system and then review it with you in detail. This was a terrific help to assure not only that the system was compliant, but attention was paid to providing the answers to an auditor […]
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…”