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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Software Development Procedure
      • Deprecated
      • Templates
        • T-012-004 Software version release
        • T-012-005 Design change control
        • T-012-006 _Product name_ life cycle plan and report_YYYY_nnn
        • T-012-007 Formative evaluation plan_YYYY_nnn
        • T-012-008 Formative evaluation report_YYYY_nnn
        • T-012-009 Validation and testing of machine learning models_YYYY_nnn
        • T-012-010 Device backup verification_YYYY_nnn
        • T-012-012 Customers product version control_YYYY_nnn
        • T-012-013 Design stage review
        • T-012-014 Summative evaluation plan_YYYY_nnn
        • T-012-015 Summative evaluation report YYYY_nnn
        • T-012-016 Software usability test guide
        • T-012-017 Integration test review
        • T-012-019 SOUP
        • T-012-020 Predetermined Change Control Plan
        • T-012-021 Product Design Phase 1 Checklist
        • T-012-022 Software Design Phase 2 Checklist
        • T-012-023 Software Development Plan
        • T-012-024 Software Candidate Release Phase 3 Checklist
        • T-012-025 Software Verification Phase 4 Checklist
        • T-012-026 Product Validation Phase 5 Checklist
        • T-012-027 Version delivery description
        • T-012-028 Software Requirement Specification
        • T-012-029 Software Architecture Description
        • T-012-030 Software Configuration Management Plan
        • T-012-031 Product Requirements Specification
        • T-012-033 Software Tests Plan
        • T-012-034 Software Test Description
        • T-012-035 Software Test Run
        • T-012-036 Software development plan
        • T-012-037 Labeling and IFU Requirements
        • T-012-038 Verified Version Release
        • T-012-039 Validated version transfer
        • T-012-040 Documentation level FDA
        • T-012-041 Software Classification 62304
        • T-012-042 Regulatory Requirement
      • GP-012 Design, Redesign and Development
      • Specific procedures
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-012 Software Development Procedure
  • Templates
  • T-012-040 Documentation level FDA

T-012-040 Documentation level FDA

Change history​

RevisionSummaryDate

Software maintenance​

Instructions

In this section, describe how software maintenance activities are managed after the PRODUCT design is finalized. To complete it:

  • Explain the risk management process post-design, according to the existing risk management plan.
  • Specify what actions are taken when new risks are identified or when new information could impact the existing risk assessment. Indicate that the risk analysis must be updated accordingly.
  • State whether the PRODUCT design has been updated, and if so, describe how the impact on risks was evaluated.
  • Reference the specific checklist reports used to document these updates and assessments:
    • Product Requirements Verification Checklist
    • Software Requirements Verification Checklist
    • Software Architecture Verification Checklist

Make sure the text clearly shows compliance with post-design maintenance procedures and provides traceability through referenced documents.

Information Provided to the User​

Instructions for use​

Instructions

In this subsection, specify:

  • The user documentation available, such as user manuals or instructions for use (IFU), that guide the proper operation of the PRODUCT.
  • The document reference or version number of the IFU.
  • Confirm that the instructions are written in a way that is understandable to the intended user and that they include all necessary operational guidance.

Labeling​

Instructions

In this subsection, detail:

  • The warnings, precautions, and other labeling elements included to inform the user of potential risks.
  • Confirm that such information is included in the IFU or other official PRODUCT documentation.
  • If applicable, cite the specific version of the IFU document that includes these labeling details.

Ensure that labeling meets the regulatory requirements for clarity, visibility, and accuracy.

Documentation Level Assessment​

StepQuestionAnswer
Can an injury or illness resulting from a software failure be life threatening?Yes, Enhanced documentation level. No, go to step 2

Documentation Level Rationale​

Instructions

Replace the placeholder text with a detailed explanation of the documentation level for the PRODUCT based on the answers to the questions above. This should include:

Considering the description Device Description, the intended use and end users, the environment of use, the answers to questions in Annex A of ISO 24971, the risks identified in the risk management file (Risk Analysis), the software requirements (T-012-028 Software Requirement Specification), the answers to questions of IEC/TR 80002-1, and the answer to above questions the documentation level of PRODUCT is: level.

Most critical risks​

ID RiskDescriptionPossible serious injury?
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T-012-039 Validated version transfer
Next
T-012-041 Software Classification 62304
  • Change history
  • Software maintenance
  • Information Provided to the User
    • Instructions for use
    • Labeling
  • Documentation Level Assessment
    • Documentation Level Rationale
      • Most critical risks
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.)