How to classify medical devices

How to classify medical devices

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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