<h1 class="entry-title">Group: FDA 483 and Warning Letter Resolution</h1>

President – Class II & III device Manufacturer

“…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 […]

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 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…”

Quality Assurance Manager – Class II and III device Manufacturer

“…The internal audit conducted by ComplianceAcuity was comprehensive and practical, with an attention to detail that provided our company insight into our own business that we did not have before. The audit was conducted with intelligence and professionalism, reflecting in depth knowledge and understanding of FDA and ISO…”