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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 Design, Redesign and Development
      • Deprecated
      • Templates
        • T-012-001 Requirements
        • T-012-003 Test run
        • 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-012-014 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-012-018 Test plan
        • T-012-019 SOUP
      • 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 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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-012 Design, Redesign and Development
  • Templates

Templates

📄️ T-012-001 Requirements

Category

📄️ T-012-003 Test run

Test type

📄️ T-012-004 Software version release

Software version

📄️ T-012-005 Design change control

Here's a list of the version releases, with a link to each one and a short summary of the changes.

📄️ T-012-006 _Product name_ life cycle plan and report_YYYY_nnn

Purpose

📄️ T-012-007 Formative evaluation plan_YYYY_nnn

Purpose

📄️ T-012-008 Formative evaluation report_YYYY_nnn

Characterization of the medical device

📄️ T-012-009 Validation and testing of machine learning models_YYYY_nnn

Description of the methodologies

📄️ T-012-010 Device backup verification_YYYY_nnn

Evidence

📄️ T-012-012 Customers product version control_YYYY_nnn

Customers product version control

📄️ T-012-014 Summative evaluation plan_YYYY_nnn

Objective

📄️ T-012-015 Summative evaluation report YYYY_nnn

Objective

📄️ T-012-016 Software usability test guide

User expertise

📄️ T-012-017 Integration test review

Description of integration test plan

📄️ T-012-018 Test plan

Description

📄️ T-012-019 SOUP

Description

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SP-012-001 Software development management
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T-012-001 Requirements
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.)