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  • Quality Manual
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    • 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
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    • 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
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    • GP-050 Data Protection
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    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
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    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
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  • GP-012 Software Development Procedure
  • Templates
  • T-012-037 Labeling and IFU Requirements

T-012-037 Labeling and IFU Requirements

Identifier​

Instructions

Unique identifier of the Labeling and IFU Requirements

Name​

Instructions

Name of software item, as defined in the software architecture, that are involved in the implementation of the Labeling and IFU Requirements

Description​

Instructions

Detailed text describing the Labeling and IFU Requirements

Related activities​

Instructions

List of activities related to the Labeling and IFU Requirements that are defined in the Software Development Procedure and linked to Jira activities.

Derived from Product Requirement Specification (PRS)​

Instructions

Indicates from which Product Requirement Specification (PRS) the Labeling and IFU Requirements is derived. This is a reference to the PRS document.

Derived from Software Requirement (SR)​

Instructions

Indicates from which Software Requirement (SR) the Labeling and IFU Requirements is derived. This is a reference to the SR document.

Risk control measure​

Instructions

Indicates whether the Labeling and IFU Requirements serves as a risk control measure to mitigate or eliminate an identified risk. The value is 'Yes' if the SR is specifically implemented as a risk control, and 'No' otherwise

Creates risk ID​

Instructions

This column lists the unique identifiers of risks that are generated as a result of the implementation or existence of the corresponding Labeling and IFU Requirements

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T-012-036 Software development plan
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T-012-038 Verified Version Release
  • Identifier
  • Name
  • Description
  • Related activities
  • Derived from Product Requirement Specification (PRS)
  • Derived from Software Requirement (SR)
  • Risk control measure
  • Creates risk ID
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.)