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    Device Master Record Index: Sl. No. Document No. Device Specifications (DS)

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    The document is a Device Master Record Index that contains specifications for a medical device. It lists 6 key documents: 1) Device Specifications, 2) Manufacturing Process Specifications, 3) Quality Assurance procedures, 4) Packaging and Labeling specifications, 5) Installation, Maintenance and Servicing specifications. Each document section describes the contents and information contained in that document for quality control and regulatory compliance purposes.

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    Device Master Record Index: Sl. No. Document No. Device Specifications (DS)

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    47 views6 pages
    The document is a Device Master Record Index that contains specifications for a medical device. It lists 6 key documents: 1) Device Specifications, 2) Manufacturing Process Specifications, 3) Quality Assurance procedures, 4) Packaging and Labeling specifications, 5) Installation, Maintenance and Servicing specifications. Each document section describes the contents and information contained in that document for quality control and regulatory compliance purposes.

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    The document is a Device Master Record Index that contains specifications for a medical device. It lists 6 key documents: 1) Device Specifications, 2) Manufacturing Process Specifications, 3) Quality Assurance procedures, 4) Packaging and Labeling specifications, 5) Installation, Maintenance and Servicing specifications. Each document section describes the contents and information contained in that document for quality control and regulatory compliance purposes.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Download as xlsx, pdf, or txt
    47 views6 pages

    Device Master Record Index: Sl. No. Document No. Device Specifications (DS)

    Uploaded by

    normal
    The document is a Device Master Record Index that contains specifications for a medical device. It lists 6 key documents: 1) Device Specifications, 2) Manufacturing Process Specifications, 3) Quality Assurance procedures, 4) Packaging and Labeling specifications, 5) Installation, Maintenance and Servicing specifications. Each document section describes the contents and information contained in that document for quality control and regulatory compliance purposes.

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    DEVICE MASTER RECORD INDEX

    Device Name:

    Sl. No. Document No.


    Device Specifications (DS)

    Manufacturing Process Specifications (MP)

    Quality assurance procedures and specifications (QA)


    Packaging and labeling specifications (PL)

    Installation, maintenance and servicing specifications (IMS)


    DEVICE MASTER RECORD INDEX

    Document Title Approved by


    Device Specifications (DS)
    Intended use
    Product Requirements Document (PRD)
    System Architecture document
    Software Requirement Specifications (SRS)

    Bill of materials (refers to the drawings, specifications,


    design document, data sheets of all the components)

    Software Output(executable files for software or firmware)


    anufacturing Process Specifications (MP)

    General Manufacturing description


    (Manufacturing process, environment, Contract
    Manufacturer's reference,...)

    Product process flow chart

    Product assembly process/diagram

    Equipments and production tools


    Jigs and fixtures details
    Equipment maintenance procedures
    Validation reports for special processes and software, if
    applicable

    Sterilization specifications, procedures, and validation


    reports, if applicable
    assurance procedures and specifications (QA)

    Quality agreement with Contract Manufacturer.

    Quality system operational procedures (QOP), if


    applicable
    Quality system forms (QF), if applicable
    Process control specifications/charts

    Control plans, instructions and acceptance criteria for


    incoming, in-process, and finished device inspection and
    testing
    Blank work order forms for recording inspection/testing
    activities, traceability, and other data for device history
    records

    Device release review/OQC checklists

    ackaging and labeling specifications (PL)

    Package drawings, specifications, procedure and labelling


    Product labels/labeling drawings

    Instruction manuals

    Storage requirements
    n, maintenance and servicing specifications (IMS)

    Installation, specifications and instructions


    Maintenance instructions

    Servicing specifications and manuals


    pproved by

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