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Our Phone Number +353 (0)61 514 744

Our Email info@OptimaTraining.ie

First Steps to Medical Device

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Course Content:

  • Introduction & Course Objectives
  • An overview of the medical device sector in Ireland / Globally
  • What are medical devices and how do they work
  • Regulations that govern the medical device sector – ISO 13485:2016 and 21 CFR Part 820 and 93/42 EEC
  • How Medical devices are classified and brought to Market within Europe, USA and Canada
  • The role of Regulatory Bodies : Competent Authority – Health Products Regulatory Authority, FDA and notified bodies BSI,NSAI TUV etc – role within manufacturing
  • The role of Cleanrooms and classification of cleanrooms
  • Good Documentation Practice (GDP)
  • Work Instructions
  • Change Control
  • Good Manufacturing Practice.
  • Device Design Systems
  • Basic Problem Solving Techniques
  • Q&A
  • Conclude & Follow Up Process