Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
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February 2014 mobile Health International regulatory perspectives Koen Cobbaert – IT Regulatory Manager
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Transcript of Koen Cobbaerts Agfa Healthcare #MWC14 #mHealth
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
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Regulators register software-only products as medical devices
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Legislative texts and guidance on medical software including mobile apps
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page 11 of total regulators draw new lines in the sand
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the future a global legislative jungle?
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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