Understanding the EU MDR
- Buy now
- Learn more
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

5. Gap Analysis & Document Management

Understand how to form an overall assessment of your MDR strategy through structured Gap Analysis. Learn the importance of document management and gain insight into tools for organising and maintaining your MDR technical files.

3 Lessons