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.

Amy Leiser, Special Counsel, Regulatory Affairs, Covington & Burling LLP
Cynthia Culmo, Senior Advisor, Covington & Burling LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2025.

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Kiana Walker2025-04-14T15:13:54-04:00