The FDA's Adoption of ISO 13485:2016 and its Impact on the QMS

Filmed on May 18, 2023 - On February 23, 2022, the United States Food and Drug Administration proposed an amendment to 21 CFR 4 and 820. The purpose of the proposed change is to better align the agency’s medical device quality management system requirements with the international consensus standard for devices, ISO 13485:2016 (the Standard), used by other regulatory authorities. This will affect quality management system (QMS) requirements for both medical devices and combination products involving both medical devices and drugs. The objective of this webinar is to inform manufacturers about FDA’s adoption of ISO 13485:2016 and how it impacts their Quality Management System and any changes that they should consider with this decision. 0:00 Introduction 3:52 Agenda 9:39 Recent Changes to ISO 13485:2016 13:15 Shadows of MDSAP 14:08 QSR & Agency Process 16:05 The Cycle of QSMR Reviews 22:01 How MDSAP Certification Helps 29:13 What Should You Do Now? 30:27 Risk Management 37:54 Planning 42:52 Design and Development 43:29 After Release of Final Draft 47:06 SGS Academy 48:43 Q&A Speakers Timothy Gooch - Medical Devices Technical Director - ISO 13485, MDSAP, Supply Chain Risk Management, SGS North America, Inc. Cindy Haight - Inside Sales Representative, Industrial & Medical Device, SGS North America, Inc. Speakers Sabrina Ippolito - Lead Auditor Cindy Haight - Inside Sales Representative, Industrial & Medical Device, SGS North America, Inc. Learn more: https://bit.ly/3SJRSWp Follow us on LinkedIn: https://bit.ly/44lmAY1