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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
      • 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
  • T-007-004 PMS evaluation report

T-007-004 PMS evaluation report

PMS: Vigilance and CAPA information​

Serious incidents​

note

Describe and characterize the serious incidents detected during the period reviewed from:

  • The device problems
  • The root cause
  • The health effects on the person(s) affected

FSCA​

note

The FSCA analysis shoud include:

  • types of actions.
  • issuing date,
  • scope of the FSCA,
  • status of the FSCA at the time of the PSUR,
  • manufacturer’s reference number,
  • a brief description of the reason for action and description of action and impacted regions.

Trend reports​

note

Describe the trends detected during the review of the indicators, non-conformities, audits results, customer feedback and other possible trends detected.

CAPAs​

note

Summarize the CAPAs on a table like the following one (that should also be included at the T-007-003 PSUR), and described with more detail the CAPAs that led to more serious harm.

Type of actionInitiation dateScopeStatusReference numberDescriptionRoot causeEffectiveness if closed

Feedback and complaints​

note

Describe the feedback and complaints received during the period analyzed that do not refer to clinical features, that will be included at the `T-007-005 PMCF evaluation report.

Regulatory requirements​

note

Summarize the revision of the webs listed at the T-007-001 PMS plan.

Cybersecurity and state of the art​

note

Summarize the revision of the webs listed at the T-007-001 PMS plan.

Record signature meaning​

  • Author: JD-004 Author name
  • Review: JD-005 Reviewer name
  • Approval: JD-001 Approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 Andy Aguilar
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T-007-003 Periodic Safety Update Report (PSUR)
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T-007-005 PMCF evaluation report
  • PMS: Vigilance and CAPA information
    • Serious incidents
    • FSCA
    • Trend reports
    • CAPAs
    • Feedback and complaints
    • Regulatory requirements
    • Cybersecurity and state of the art
  • Record signature meaning
  • Template signature meaning
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.)