Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth

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Information about Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
Health & Medicine

Published on March 14, 2014

Author: 3GDR

Source: slideshare.net

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

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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

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