Validation Tests and Certification for Azure

Question

We are implementing Azure. ISO 13485:2016 requires us to obtain evidence for validation and a certification of this validation for our records. Is there one I can reference for this evidence? Thanks -casey

Answer 1

Hi @Casey Maynard ,

a lot of compliance offerings/regulatory compliance standards you can find here:
https://learn.microsoft.com/en-us/compliance/regulatory/offering-home?culture=en-us&country=US&view=o365-worldwide

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(If the reply was helpful please don't forget to upvote and/or accept as answer, thank you)

Regards
Andreas Baumgarten

Answer 2

Thanks for reaching here! Could you please elaborate your query to help you better on this, If you are looking for ISO 13485? As its mentioned in the document
“You can use Azure ISO 9001 certification for your own quality management requirements including sector-specific standards for quality management systems, such as: ISO 13485 for medical devices”

Please let us know if further query or issue remains.

Answer 3

That seems to cover my question enough. For 3rd party applications, we have been provided the actual completed tests for evidence that the functionality of the application was successful. FDA and ISO 13485:2016 auditors have found this documentation enough. Thanks.