Software in Medical Devices, by MD101 Consulting

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2024 templates - SRS, SAD and SDS

The templates present on this site deserve a refresh. We continue with the 2024 version of the Software Requirement Specification, the Software System Architecture Description, and the Software Design Specification.

Here are the links to the templates:

They were updated with:

  • Recommendation from FDA guidances,
  • Requirements coming from IEC 81001-5-1,
  • Requirements coming from GDPR, and other security references.

The Software Detailed Design Description (SDD) document was renamed to Software Design Specification (SDS) to match FDA acronyms.

I share these templates with the conditions of CC-BY-NC-ND license.



Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License.


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