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The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market; and offer technical topic updates on biocompatibility, artificial intelligence, and radiological health. Chapters: 0:00 Intro 4:06 - Welcome to REdI 2022 Device Track, Part 1 - Elias Mallis 24:49 - Medical Device Regulatory Framework: Where to Start? - Kendra Holter 1:05:23 - Biocompatibility Basics - Jennifer Goode 2:03:08 - Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program - Scott Colburn 2:43:00 - Detangling the 510(k) Process - Andrew Sprau 4:24:46 - CDRH Portal: Overview and Feature Walkthrough - Nelson Anderson 5:07:32 - Reduced Medical Device User Fees: Small Business Determination (SBD) Program - Jason Brookbank 6:05:15 - Welcome to REdI 2022 Device Track, Part 2 - Joseph Tartal 6:13:47 - Managing Medical Device Nonconforming Product with Quality - Ruth Bediakoh 6:53:39 - Handling Medical Device Complaint Files with Quality - Tonya Wilbon 7:33:30 - CDRH Day One Closing Remarks - Joseph Tartal