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    Device Master Record

    Uploaded by

    kuttyj
    The document defines four types of records that are important for medical device development and manufacturing: the Device Master Record contains current device specifications and manufacturing procedures; the Device History Record includes test results for each manufactured device; the Design History File is a compilation of design records showing the evolution of a device's development; and the Technical File contains information from the other files plus additional items needed for CE marking.

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    Attribution Non-Commercial (BY-NC)
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    Device Master Record

    Uploaded by

    kuttyj
    613 views1 page
    The document defines four types of records that are important for medical device development and manufacturing: the Device Master Record contains current device specifications and manufacturing procedures; the Device History Record includes test results for each manufactured device; the Design History File is a compilation of design records showing the evolution of a device's development; and the Technical File contains information from the other files plus additional items needed for CE marking.

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    The document defines four types of records that are important for medical device development and manufacturing: the Device Master Record contains current device specifications and manufacturing procedures; the Device History Record includes test results for each manufactured device; the Design History File is a compilation of design records showing the evolution of a device's development; and the Technical File contains information from the other files plus additional items needed for CE marking.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    613 views1 page

    Device Master Record

    Uploaded by

    kuttyj
    The document defines four types of records that are important for medical device development and manufacturing: the Device Master Record contains current device specifications and manufacturing procedures; the Device History Record includes test results for each manufactured device; the Design History File is a compilation of design records showing the evolution of a device's development; and the Technical File contains information from the other files plus additional items needed for CE marking.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 1

    Device Master Record (DMR): Contains all of the device specifications and procedures used for its manufacture.

    Typically only current (not obsolete) procedures, schematics, BOM's, etc. are kept here.

    Device History Record (DHR): Is a compilation of the test results for each manufactured device. Each device (or lot) should have a DHF that fully describes the tests that were done, who did them, and date (complete traceability on all tests).

    Design History File (DHF): A compilation of records that contain the history of the design, such as validations, verifications, qualifications, environmental testing, project plans, risk management activities, meeting minutes, etc. Often this will include all revisions of a procedure, schematic, etc. so that as the development process evolves this traces the changes that were made.

    Technical File: Only required for CE Mark (not an FDA thing). Its contents will include some of the items from the DHR and DHF, plus items not in the DHR and DHF, such as statements about substantial equivalence or clinical trials. Most important item in here is the Essential Requirements matrix. The lengthy list of items is described in the relevant MDD, perhaps MDD 93/42 in your case.

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