Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth

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  • 1. February 2014 mobile Health International regulatory perspectives Koen Cobbaert – IT Regulatory Manager
  • 2. software-only products* can be a medical device (if they meet the definition) *including mobile apps
  • 3. 3 Regulators register software-only products as medical devices
  • 4. 4 Legislative texts and guidance on medical software including mobile apps
  • 5. 5
  • 6. 6
  • 7. 7
  • 8. 8
  • 9. 9
  • 10. page 11 of total regulators draw new lines in the sand
  • 11. 15 the future a global legislative jungle?
  • 12. 16
  • 13. 17 simplicity the most difficult thing of all
  • 14. IMDRF: another road
  • 15. IMDRF: risk types
  • 16. less regulatory burden without loss of regulatory oversight IMDRF: regulatory controls
  • 17. the end