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    • GP-001 Documents and records control
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    • GP-007 Post-market surveillance
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    • GP-018 Infrastructure and facilities
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    • GP-023 Change control management
      • R-023-001_001 Change control
      • R-023-001_002 Change control
      • R-023-001_003 Change control
      • R-023-001_004 Change control
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
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  • GP-023 Change control management
  • R-023-001_004 Change control

R-023-001_004 Change control

Description​

  • Change name: Registration of our medical device in Brazil
  • Change description: According to one of the quality objectives established for 2024 (quality objective 03), we are in the process of registering our medical device in Brazil to obtain the ANVISA (Competent Authority in Brazil) approval. This change is classified as a modification to the Quality Management System (QMS) because it introduces new (or updated) processes and documentation specific to the Brazilian market.
  • Source of change: internal, as part of quality objectives 2024.

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): the change does not alter the fundamental structure, scope, or core processes of the system. Instead, the change involves the addition of region-specific adaptations to pre-existing QMS elements.
  • Risk analysis impact: the risk analysis associated with the device and the QMS remains unchanged as this change represents adaptations of pre-existing processes rather than the introduction of new or high-risk activities.
  • Quality documentation impact:
    • Quality manual (section Applicable regulations and standards)
    • New procedure for applicable requirements to enter the Brazilian market, vigilance and post-market activities in Brazil
    • Creation of R-001-002 Manufacturer Declaration of Conformity for Brazil
    • Creation R-012-004 Software version release for Brazil
    • R-010-001 Suppliers evaluation
    • Legit.Health Plus IFU

Approval​

The change is approved.

Plan​

  • Update the section Applicable regulations and standards of the Quality manual to include compliance with applicable regulations in Brazil.
  • Create a procedure to explain the process and requirements for placing medical devices in the Brazilian market, vigilance and post-market activities.
  • Creation of the record R-001-002 Manufacturer Declaration of Conformity for Brazil to state the conformity of the medical device with the applicable regulations in Brazil.
  • Creation of the record R-012-004 Software version release for Brazil to document the release of the software as a medical device once we obtain the ANVISA approval.
  • Update the record R-010-001 Suppliers evaluation to include the evaluation of the selected Authorised Representative in Brazil.
  • Update the Legit.Health Plus IFU to include the information of our Authorised Representative in Brazil.

Implementation​

Implementation date: 2024-12-15

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-005
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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.)