Published on March 14, 2014
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
page 11 of total regulators draw new lines in the sand
15 the future a global legislative jungle?
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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