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February 2014
mobile Health
International regulatory perspectives
Koen Cobbaert – IT Regulatory Manager
software-only products*
can be
a medical device
(if they meet the definition)
*including mobile apps
3
Regulators register software-only products
as medical devices
4
Legislative texts and guidance on medical software
including mobile apps
5
6
7
8
9
page 11 of total
regulators draw new lines in the sand
15
the future
a global legislative jungle?
16
17
simplicity
the most difficult thing of all
IMDRF: another road
IMDRF: risk types
less regulatory burden
without loss of regulatory oversight
IMDRF: regulatory controls
the end
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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Transcript of "Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth"

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