Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth

•

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3GDR

Salud y medicina

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

less regulatory burden
without loss of regulatory oversight
IMDRF: regulatory controls

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