Introduction to the MDR

This video provides an overview of the EU MDR - the central piece of legislation that oversees all activities in the medical device sector.

Understanding the EU MDR

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1. Introduction

Introduction to the MDR

Supporting Information - Understanding the EU MDR

Structure of the MDR

MDR requirements

What is a medical device

2. Understanding requirements

Classifying medical devices

Making devices available on the market

General Safety and Performance Requirements (GSPRs)

3. QMS, PMS & Risk Management

Quality Management Systems & Post-Market Surveillance

Basic principles of Risk Management

Benefits of Risk Management

4. Clinical Evaluation

Clinical Evaluation & CERs

Basic principles of planning a CER

5 common pitfalls for a CER

Our Clinical Evaluation services

5. Gap Analysis & Document Management

Gap Analysis Tool

Document Management

Importance of Document Management