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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-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • 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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-007 Post-market surveillance
  • Templates
  • T-007-003 Periodic Safety Update Report (PSUR)

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

Table of contents

  • General information
  • Executive summary
  • Device description
  • Volume of sales
  • Size and other characteristics of the population using the device
  • PMS: Vigilance and CAPA information
    • Serious incidents
    • FSCA
    • Trend reports
    • CAPAs
  • PMCF information
    • Feedbacks and complaints from users, distributors and importers
    • Scientific literature review of relevant specialist or technical literature
    • Public databases and/or registry data
    • Publicly available information about similar medical devices
    • Other data sources
    • Specific PMCF information
  • Summay and conclusions
    • Validity of the collected data
    • Overall conclusions
    • Actions taken by the manufacturer
  • Record signature meaning
  • Template signature meaning

General information​

Description
Manufacturer information
Medical device(s) covered by this PSUR
Notified body name and organization number
PSUR reference number assigned by the manufacturer
Version number of the PSUR
Data collection period covered

Executive summary​

It will content a brief overview of the PSUR content and an overall conclusion in relation to the benefit-risk determination.

Device description​

Description
Classification
Date from first EC /EU Certificate issued
Status of the device
Intended purpose
Indications
Contra-indications
Target population
Basic UDI-DI
Trade name
Product version
European Medical Device Nomenclature (EMDN)
Product version
note

Status of the device can be:

  • on the market,
  • no longer placed on the market,
  • recalled,
  • field safety corrective action initiated.

Volume of sales​

note

Data should be presented by year to year.
Method should be consisten throughout the PSUR in all areas to allow for a comparison of data.

Size and other characteristics of the population using the device​

note

  • Estimate and evaluate the number of patients exposed, and the usage of the device in different patient populations.

  • If possible, consider demographic aspects.

PMS: Vigilance and CAPA information​

Serious incidents​

note

Characterize the data from:

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

FSCA​

note

The summary 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​

CAPAs​

Type of actionInitiation dateScopeStatusReference numberDescriptionRoot causeEffectiveness if closed

PMCF information​

Feedbacks and complaints from users, distributors and importers​

note

Group complaints, establish the occurence rate and refere whether they have led to initiation of CAPAs

Scientific literature review of relevant specialist or technical literature​

Public databases and/or registry data​

note

List all registried reviewed including the name of the reference and if it is prospective or retrospective data collection.

Publicly available information about similar medical devices​

note

Compile the type and location of the information, and a comparison of the devices considering safey and performance.

Other data sources​

note

For example real-world data, with specific reference to safety and performance of the device.

Specific PMCF information​

note

This section will include a summary of the finding generated from the analsis of specific PMCF activities performed, and the conclusions documented in the T-007-005 PMCF evaluation report.

Summay and conclusions​

Validity of the collected data​

Overall conclusions​

  • New or emerging risks
  • New benefits
  • Benefit-risk profile (changed or not)

Actions taken by the manufacturer​

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-007-002 Post-Market clinical follow-up (PMCF) Plan
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T-007-004 PMS evaluation report
  • General information
  • Executive summary
  • Device description
  • Volume of sales
  • Size and other characteristics of the population using the device
  • PMS: Vigilance and CAPA information
    • Serious incidents
    • FSCA
    • Trend reports
    • CAPAs
  • PMCF information
    • Feedbacks and complaints from users, distributors and importers
    • Scientific literature review of relevant specialist or technical literature
    • Public databases and/or registry data
    • Publicly available information about similar medical devices
    • Other data sources
    • Specific PMCF information
  • Summay and conclusions
    • Validity of the collected data
    • Overall conclusions
    • Actions taken by the manufacturer
  • 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.)