Regulatory Requirements on Medical Devices

This is how your training course could look like:

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Please note that we need about 3 months preparation for the organisation of your in-house training course.

08:00 – 08:30 Welcome, Introduction, Presentation of the Speaker
08:30 – 10:30 Regulatory Requirements in Europe and Harmonisation
  • Regulation
  • ISO Norms
  • IMDRF/GHTF Guidelines
  • MedDev Guidelines
  • Notified Body Recommendations
10.30 - 10.45 Break
10.45 - 12.00 Regulatory Requirements at the FDA
  • CFR 820 ff
  • Guidelines
12.00 - 12.45

Differences between EC and FDA Requirements

  • Differences and common interests

 

12.45 - 13.45 Lunch
13.45 - 15.15

CE-Certification

  • Requirements of the EC Regulation
  • Use of harmonised norms
  • Certification Process
15.15 - 15.30 Break
15.30 - 17.00 Technical Documentation
  • Content of the TD
  • TD as a linking document between production and quality control
  • Change Management
17.00 - 18.15 Final Discussion Forum

 

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