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Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
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.
11.
page 11 of
total regulators draw new lines in the sand
12.
13.
14.
15.
15 the future a global
legislative jungle?
16.
16
17.
17 simplicity the most difficult
thing of all
18.
IMDRF: another road
19.
IMDRF: risk types
20.
less regulatory burden without
loss of regulatory oversight IMDRF: regulatory controls
21.
the end
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