Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction

Identify the background, purpose, and regulatory requirements of the Quality System Regulation. Learn key requirements of the QS Regulation.  Understand why and how to mitigate QS Regulation noncompliance.

Janet Book, Principal Program Lead Medical Devices, NSF International

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2023

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