MEDIcept Inc.
F. David Rothkopf is an accomplished professional with extensive experience in quality assurance, regulatory compliance, and operational leadership within the medical device and software industries. Since April 1997, Rothkopf has served as President of MEDIcept, conducting quality system audits and providing regulatory assistance for various medical device manufacturers. In addition, Rothkopf is President of SON Medical and previously led Abacus Ventures as President. Other significant roles include Vice President of Operations, Quality and Regulatory Affairs at mRAD, and Chief of Operations at Zmed Inc. Rothkopf's proficiency spans over 400 compliance audits and multiple FDA submissions, complemented by educational credentials, including an MBA from Boston University and multiple degrees in mechanical and manufacturing engineering from Worcester Polytechnic Institute.
MEDIcept Inc.
1 followers
MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. We are an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, Clinical, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs. MEDIcept will help you navigate the complex FDA and international regulatory pathways, reduce business risk, and decrease time-to-market while maximizing your potential for success. Every client and every issue is unique. We customize our solutions to fit your needs. With a retention rate of over 90%, we can promise that you will benefit from working with us.