Introduction and overall course structure

Introduction and overall course structure

This video gives an overview of the structure of the training course and places the videos that follow into context.

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