My lessons

An educational program developed by the Institute of Image-Guided Surgery of Strasbourg, University of Strasbourg and in partnership with IRCAD.

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Lessons
1.
Lessons

THE MEDICAL DEVICE APPROVAL PROCESS

Introduction

The lesson includes:

Introduction

Video

Quiz

PDF

Speakers

John ODea

Lesson description:

What takes to bring your medical device to market? As with drugs, medical devices need to go through a regulatory process evaluating safety and efficacy. This lecture covers EU and USA regulatory body requirements and underlines the differences in between the two systems.