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Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
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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

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