Many companies developing medical software, especially the smaller app developers, have difficulties applying the EN62304 standard. For that reason a number of experts under the auspices of Team NB started work on an FAQ document shedding more light on how this standard works, as to enable companies to conduct more productive discussions with their notified body and assess their own software better. The document has been reviewed by a voluntary team consisting of a few notified bodies as well as the ISO gr [...]
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