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QMSQMS
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
    • 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
      • Specific procedures
        • T-028-001 AI Description
        • T-028-002 AI Development Plan
        • T-028-003 Data Collection Instructions
        • T-028-004 Data Annotation Instructions
        • T-028-005 AI Design Checks
        • T-028-006 AI Development Report
        • T-028-007 AI Retraining Report
        • T-028-008 AI Revaluation Report
        • T-028-009 AI Release Report
        • T-028-010 V&V Release Report
    • 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-028 AI Development
  • Specific procedures

Specific procedures

📄️ T-028-001 AI Description

📄️ T-028-002 AI Development Plan

📄️ T-028-003 Data Collection Instructions

📄️ T-028-004 Data Annotation Instructions

📄️ T-028-005 AI Design Checks

📄️ T-028-006 AI Development Report

📄️ T-028-007 AI Retraining Report

📄️ T-028-008 AI Revaluation Report

📄️ T-028-009 AI Release Report

📄️ T-028-010 V&V Release Report

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GP-028 AI Development
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T-028-001 AI Description
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.)