koen cobbaerts agfa healthcare #mwc14 #mhealth
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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
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