“…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 […]
<h1 class="entry-title">Group: Internal Audits</h1>
Director of Operations – Class II and III device Manufacturer
“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly […]
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…”
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…”
Manager, Quality Systems – Class II & III device Manufacturer
“…We were very pleased with Kevin’s work. He was very knowledgeable regarding the industry Standards and Regulations. He was provided copies of our company’s procedures prior to the scheduled audit and had a good understanding of them in order to perform the audit of our systems and processes. His reports were clear and precise and […]
Director of Operations – Class II and III device Manufacturer
“…I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding […]
Director of Operations – Class III device Manufacturer & Distributor
“…ComplianceAcuity’s audit approach was thorough, yet personable, professional, pragmatic and supremely constructive when compared to prior outsourced audits. ComplianceAcuity’s audit findings were educational and informative thereby enabling us to focus our resources in the right places…”
Director of Operations – Class III device Manufacturer & Distributor
“…Traditionally our FDA compliance responsibilities have been unclear to us in our unique business model. The explanation that ComplianceAcuity provided to our management team was the most thorough, tactful, and precise that we’ve ever received. FDA has since concurred with ComplianceAcuity’s analysis and we continue to rely on ComplianceAcuity’s insight daily as we operate our […]
Senior Process and Quality Manager
“…Awesome job, but we already knew from your on-site work that you are professional, thorough, and willing to help us become a fully compliant and quality-driven supplier of high-performance medical equipment…”
Sr. Quality Engineer – Class II & III device Manufacturer
“…I found your knowledge and experience to be top notch. You were also very easy to communicate and work with…”