Software in Medical Devices, by MD101 Consulting

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New Templates: Data Management Plan and Data Management Report

After talking about AI in a series of articles, and especially about the data management process, we introduce two new templates: the Data Management Plan and Data Management Report.

Current templates present in the Software Development Templates Repository are adapted to classical software development and IEC 62304. But templates for data-driven design were missing. This loophole is fixed by adding these two new templates!

Here are the links to these templates:


They can be used:

  • For the data management plan: in parallel to / together with the software development plan,
  • For the data management report: it can be part of the software release, it is an artifact for both configuration management and design V&V.


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



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


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