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      • R-023-001_001 Change control
      • R-023-001_002 Change control
      • R-023-001_003 Change control
      • R-023-001_004 Change control
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  • GP-023 Change control management
  • R-023-001_003 Change control

R-023-001_003 Change control

Description​

  • Change name: DHF migration from Confluence to Github
  • Change description: the DHF for Legit.Health Plus device was stored in Confluence. After an internal revision of the DHF documents to address the third round of questions of BSI about technical documentation, we decided to move the DHF to Github, where procedures and records of our QMS are stored. This decision is coming from the need of managing the DHF documents in a better and more efficient way.
  • Source of change: internal, as part of continuous improvement

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities)
    • No (it does not require notification to Regulatory Authorities): it is a change to improve the management of the technical documentation (DHF).
  • Risk analysys impact: the proposed change does not modify any existing risks and does not introduce new risks in the management of documentation. On the contrary, the change decreases risks of non-authorised modification in the technical documentation.
  • Quality documentation impact:
    • all DHF documents because they are moved from Confluence to Github
    • GP-001 Control of documents
    • GP-012 Design, Redesign and Development and templates
    • Legit.Health Plus STED_2023_001
    • R-TF-012-006 Lifecycle plan and report_2023_001

Approval​

The change is approved.

Plan​

  • Revision of GP-001 Control of documents to remove reference to Confluence and explain that DHF is now stored in Github
  • Revision of GP-012 Design, Redesign and Development to remove reference to Confluence, explain that DHF is now stored in Github and explain the reviewed structure of DHF (addition of test plans as part of the DHF)
  • Revision of templates of GP-012 Design, Redesign and Development and addition of new template for test plan
  • Revision of Legit.Health Plus STED_2023_001 to update location where DHF is stored (section Technical description of the product)
  • Revision of R-TF-012-006 Lifecycle plan and report_2023_001 to update location where DHF is stored and to add the test plan as part of the DHF.

Implementation​

Implementation date: 2024-08-09

Record signature meaning​

  • Author: JD-004
  • Review: JD-005
  • Approval: JD-003
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  • Description
  • Impact analysis
  • Approval
  • Plan
  • Implementation
  • Record signature meaning
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)