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Adds regulations documents #21

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@AnilMistry AnilMistry commented Aug 17, 2021

Added documentation folder.

(opened pull request to make progress visible)

Decisions to be made:

  • Is known_anomalies.md needed? (FDA)
  • Is Architecture_design_chart.md needed? (FDA)
  • is software_description.md needed? (FDA)
  • is predicate.yml needed? (FDA)
  • [ ]

To do:

  • Add CSC icon to .md
  • Change level_of_concern.md to CE marking equivilent
  • Update "Level of concern" in device.yml
  • Create Architecture Design flowchart for dicomserver/AIDE
  • Remove all Innolitics references, making it relevant to CSC
  • Write a release protocol, for example updating release_history.yml (probably better to have in GSTT_CSC_QMS)
  • Remove 510k number requiment from predicate.yml
  • Edit software_design_specification.md "Definitions" section to make it relevant to typical CSC projects
  • [ ]

@AnilMistry AnilMistry requested review from hshuaib90 and laurencejackson and removed request for hshuaib90 August 17, 2021 12:45
@laurencejackson laurencejackson linked an issue Aug 18, 2021 that may be closed by this pull request
@laurencejackson
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@AnilMistry, could you advise on what templates it might be good for us to include to resolve this PR?

Do we want to include blank copies of the necessary documentation or do you think would it be better to expand the template documentation to make it clear where to find the necessary templates in the GSTT-CSC/QMS repo? The former is easier for users, but the latter is probably the neater way.

@hshuaib90
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@laurencejackson @AnilMistry it would be good to agreement from others in this thread as they'll be the end users. We shouldn't include separate copies of documents as then it becomes uncontrolled. I think links to documents are best in the instance, but eventually it would be great to have a CLI that just pulls the templates you need automatically.

@laurencejackson laurencejackson removed their request for review July 11, 2024 09:35
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MLOps & Medical Device Regulations compliance
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