Software in Medical Devices, by MD101 Consulting

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Essential list of guidances updated

The last time I updated my essential list of guidances was in 2012. Today I've done a full refresh of that page with:

  • Change of GHTF to IMDRF,
  • Update of links to TEAM-NB website,
  • Update of FDA guidances, especially the brand new guidance about mobile medical applications.


I hope you'll find all relevant regulatory information about software on that essential list of guidances.



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