speaker-photo

Tim Gooch

Technical Director, Knowledge at SGS Life Sciences Management Systems and Supply Chain

Tim Gooch has over 40 years of experience in medical devices, including the design and development of surgical implants for the neck and above, active implantable devices, and audiological active devices. He has served the testing, inspection, and certification business since 2012 including as global manager for MDSAP at SGS. His current role as technical director includes quality system certifications for medical devices, cosmetics, and pharmaceuticals.

11:30 a.m.-12:15 p.m.

Thursday October 31,  2024

Extending Your Global Reach and Minimizing Your Compliance Exposure at Home

MDSAP (the Medical Device Single Audit Program) helps medical device manufacturers cast a broader net into global markets with minimum effort. It is a highly structured program that has gained traction since 2016 and is now building momentum with greater recognition. Building on the framework and success of the MDSAP program, the U.S. FDA has adopted ISO 13485 as the recognized framework for design and manufacturing compliance for medical devices with recent announcements of the Quality System Management Regulations (QMSR), replacing the Quality System Regulation promulgated in 1996. This session will highlight history, background, summaries of current and historical activities, and personal insights from conversations with regulatory leaders on what manufacturers should be doing now and what to expect from FDA and the most current perspectives. It will also cover how participation in the MDSAP program will not only build strength in your system for improvement but will prevent scheduled visits from FDA as long as you are participating—a clear and measurable benefit.