Medical Affairs Training Course
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1. Understanding the EU MDR

Introduction and overall course structure
Introduction to the MDR
Medical Affairs Manual
Structure of the MDR
What is a medical device?
Making devices available on the market
How to classify medical devices
General Safety & Performance Requirements
Quality Management Systems & Post-Market Surveillance
Risk Management
Clinical Evaluation
MDR requirements summary
2. Reviewing literature for MDR submissions

Literature Reviews introduction
Literature Reviews in context
Principles of a Literature Review
Introduction to Literature Review policy
Literature Review Policy
Introduction to search protocol
Example search protocol
Working with PubMed
Working with Google Scholar
Appraising a literature source
The importance of grammar & presentation
Literature review summary & post-course exercise
Post-course exercise
Beyond The Ward eBook 3rd Edition

Medical Affairs Training Course

Our training course offers an opportunity to understand the medical device regulation industry and to develop medical device regulation skills & knowledge.