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

Explore the background, purpose and regulatory requirements of the Quality System Regulation. Become familiar with the regulatory requirements for device manufacturing and distribution. Differentiate between International Standards Organization (ISO) and QSR requirements.

Elaine H. Tseng, Partner, King & Spalding LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in November 2021. 

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