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    FRM-04-02 - Desc-Risk Management Report Form (GG-JUN22) - Final

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    nida.murtaza.mutahir
    ISO 13485 RISK MANAGEMENT REPORT FORM TEMPLATE

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    FRM-04-02 - Desc-Risk Management Report Form (GG-JUN22) - Final

    Uploaded by

    nida.murtaza.mutahir
    9 views2 pages
    ISO 13485 RISK MANAGEMENT REPORT FORM TEMPLATE

    Original Title

    FRM-04-02_Desc-Risk Management Report Form (GG-JUN22)_Final

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    ISO 13485 RISK MANAGEMENT REPORT FORM TEMPLATE

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    9 views2 pages

    FRM-04-02 - Desc-Risk Management Report Form (GG-JUN22) - Final

    Uploaded by

    nida.murtaza.mutahir
    ISO 13485 RISK MANAGEMENT REPORT FORM TEMPLATE

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 2

    Document Title Document Description Version No.

    PDPROJ-XX-RMR PROJECT TITLE RISK MANAGEMENT REPORT 0

    1 OVERVIEW
    The information within the Risk Management Plan, Risk Assessment, Design Verification, and Design
    Validation has been evaluated. Based on this review, [insert product] poses risks less than or equal risk to
    alternative devices. No new concerns were raised during the course of design and development.

    2 RISK MANAGEMENT PLAN


    The Risk Management Plan was reviewed to confirm that it was appropriately implemented. The plan was
    followed as identified without deviation. The following documents capture the risk management
    deliverables for each project phase.

    Project Phase Risk Management Deliverable Document


    Planning Risk Management Plan Risk Management Plan
    System Risk Analysis (hazard
    User Needs Risk Analysis in Greenlight Guru
    identification and source identification)
    System Risk Analysis (hazard
    Design Input Risk Analysis in Greenlight Guru (revised)
    identification and source identification)
    System Risk Evaluation
    Design Output Risk Assessment in Greenlight Guru
    Risk Assessment (product & process)
    Risk Control Risk Assessment in Greenlight Guru
    Design Verification
    Residual Risk Acceptance (revised)
    Risk Control
    Risk Assessment in Greenlight Guru (revised)
    Design Validation Residual Risk Acceptance
    Risk Management Report
    Risk Management Report
    Production and Post-Production Risk
    Risk Assessment in Greenlight Guru (revised)
    Market Release Management
    Risk Management Report (revised)
    Revised Risk Management Report

    3 OVERALL RESIDUAL RISK

    3.1 Per the Risk Assessment and the risk acceptability criteria defined in the [insert product] Risk
    Management Plan, all risk has been reduced to an acceptable level.

    Work Form Reference: FRM-04-02; Risk Management Report Form; Version No.: 0
    Document Title Document Description Version No.
    PDPROJ-XX-RMR PROJECT TITLE RISK MANAGEMENT REPORT 0

    4 PRODUCTION AND POST-PRODUCTION RISK

    4.1 Production Risk

    4.1.1.1 Potential sources of risk along with actions taken/required are identified below.
    Source Action
    [list action]
    [list source]
    [add more rows, as necessary]

    4.2 Post-Production Risk


    The following processes are in place to monitor post-production information:
     Non-conformances
     CAPAs
     Internal Audits
     Customer Complaints
     Customer Feedback
     Change Orders
     Competitor product review / analysis (via sources such as FDA MAUDE)

    Work Form Reference: FRM-04-02; Risk Management Report Form; Version No.: 0

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