Post Marketing Issues for Medical Devices: An Introduction

Review the definitions and purposes of complaint handling, Medical Device Reporting (MDR), recalls, corrections and removals, safety alerts, and ongoing monitoring/ postmarket surveillance. Examine risk communication initiatives.

Michael Chellson, Principal Consultant, NSF International
Dhanmati Rupnarine, Principal Consultant, NSF International

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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