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  • 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-012-004 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-012-028 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-012-037 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
        • T-012-043 Traceability Matrix
      • GP-012 [Old version] 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-028 AI Development
    • GP-029 Software Delivery And Comissioning
    • 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
  • Public tenders
  • Procedures
  • GP-012 Design, redesign and development
  • Templates

Templates

📄️ 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-012-013 Design stage review

General information

📄️ 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-012-019 SOUP

Description

📄️ T-012-020 Predetermined Change Control Plan

Device identification

📄️ T-012-021 Product Design Phase 1 Checklist

Process Overview

📄️ T-012-022 Software Design Phase 2 Checklist

Actors

📄️ T-012-023 Software Development Plan

Software development project plan

📄️ T-012-024 Software Candidate Release Phase 3 Checklist

Actors

📄️ T-012-025 Software Verification Phase 4 Checklist

Actors

📄️ T-012-026 Product Validation Phase 5 Checklist

Actors

📄️ T-012-028 Software Requirement Specification

Identifier

📄️ T-012-029 Software Architecture Description

Object

📄️ T-012-030 Software Configuration Management Plan

Object

📄️ T-012-031 Product Requirements Specification

PRS-XYZ

📄️ T-012-033 Software Tests Plan

Change history

📄️ T-012-034 Software Test Description

Change history

📄️ T-012-035 Software Test Run

Change history

📄️ T-012-037 Labeling and IFU Requirements

Identifier

📄️ T-012-038 Verified Version Release

Linked Requirements

📄️ T-012-039 Validated Version Transfer

📄️ T-012-040 Documentation level FDA

Change history

📄️ T-012-041 Software Classification 62304

Change history

📄️ T-012-042 Regulatory Requirement

Change history

📄️ T-012-043 Traceability Matrix

A traceability matrix serves as a bridge between risks, requirements and testing activities, ensuring that all risks/requirements are adequately mitigated and covered by test cases. The traceability matrix shows forward traceability, that is splitted in 3 parts, linking Risks to SRS mitigation, PR to SRS and finally SRS to Test Cases.

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T-012-018 Test plan
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T-012-004 Software version release
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