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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
      • Templates
        • T-007-001 Post-Market Surveillance (PMS) Plan
        • T-007-002 Post-Market clinical follow-up (PMCF) Plan
        • T-007-003 Periodic Safety Update Report (PSUR)
        • T-007-004 PMS evaluation report
        • T-007-005 PMCF evaluation report
        • T-007-006 Sanitary alerts databases
    • 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 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-007 Post-market surveillance
  • Templates

Templates

📄️ T-007-001 Post-Market Surveillance (PMS) Plan

Purpose

📄️ T-007-002 Post-Market clinical follow-up (PMCF) Plan

Objective

📄️ T-007-003 Periodic Safety Update Report (PSUR)

General information

📄️ T-007-004 PMS evaluation report

PMS: Vigilance and CAPA information

📄️ T-007-005 PMCF evaluation report

PMCF evaluation report details

📄️ T-007-006 Sanitary alerts databases

Databases

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GP-007 Post-market surveillance
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T-007-001 Post-Market Surveillance (PMS) Plan
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.)