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Location: MedTech Theater
Title: U.S. Food and Drug Administration to Adopt ISO 13485
Event Type: Show Floor Education
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.
Objective
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.
Agenda
Introduction
What has led FDA to this announcement
Differences in 21 CFR 4/820 and ISO 13485:2016
What FDA is saying about the adoption of ISO 13485:2016
How to plan for needed changes
How certification to MDSAP changes helps you in the transition
Q&A
