“…The bottom line is that, due to ComplianceAcuity’s efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I […]
<h1 class="entry-title">Group: FDA 483 and Warning Letter Resolution</h1>
– 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…”
– QA Manager – Class II device Manufacturer
“…ComplianceAcuity ensured that our best interests were always priority #1…”
– Business Development – Class II device Virtual Manufacturer
“…I appreciate all the assistance you have provided and look forward to working with you in the future…”
– QA Director and VP of R&D – Virtual Manufacturer of Class III implantable devices
“…We were quite impressed with your abilities…”
– 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 […]
– 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…”
– QA Manager – Class II device Manufacturer
“…The personal approach Kevin took in interacting with us was a nice touch. He is very patient in listening to our questions and thorough in his response to these questions…”
– Sr. QA Manager, Design & Development
“…The service ComplianceAcuity provided was outstanding in its simplicity and directness in application of Design Control compliance…”
– Director of Operations – Class II and III device Manufacturer
“…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 supports our goals to grow our business…”