EN62304

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Updates, patches, add-ons, plugins & the Blue Guide

Here is some follow up on the previous Blue Guide post: the new version of the Blue GuideĀ is the first to address software updates to CE marked products, including software. For the…

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Team NB FAQ on EN62304 standard for software lifecycle processes

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…

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