Introduction to U.S. FDA Medical Device Regulations скачать в хорошем качестве

Introduction to U.S. FDA Medical Device Regulations

Get In Touch with a Regulatory Expert: https://www.registrarcorp.com/contact... Follow us on social media:   / registrar-corp     / registrarcorp   X / https://x.com/registrarcorp Join Registrar Corp’s experts as they dive deep into the fundamentals of medical device regulation in the United States. This comprehensive session will cover everything from device classification and 510(k) requirements to the crucial aspects of registration, labeling, and UDI (Unique Device Identification) compliance. Whether you're a medical device company looking to enter the U.S. market or aiming to expand your footprint, this session provides essential insights to navigate the complex regulatory landscape. Learn the ins and outs of compliance, ensuring your products meet FDA standards. Remember, #ExemptIsNotUnregulated—understanding these requirements is critical for success in the U.S. market! 0:00 Introductions 3:33 U.S. FDA 7:15 FDA Medical Device Definition 18:13 510k exempt 20:45 Premarket Notification (510k) 24:41 What is software as a medical device? 37:24 Registration and Listing Process Overview 43:43 Establishment Inspections 49:23 Official Correspondent 1:06:36 Medical Device Services by Registrar Corp