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

2. Understanding requirements

Dig deeper into working with the MDR and build the basis for a successful strategy. Understand how to classify devices and perform a GSPR relevancy analysis, and gain further insight into requirements for placing devices on the market.

3 Lessons