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  • 1.  Analytical Validation

    Posted 07-Feb-2024 11:09

    Hello !  Can anyone point me in the right direction for analytical method validation requirements/standards/guidance specific to medical devices, for example - is there an equivalent to ICH Q2(R2) – Validation of Analytical Procedures for medical devices?  Thank you in advance!



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    Sandra Veenstra
    Chief Regulatory Officer
    Moncton NB
    Canada
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  • 2.  RE: Analytical Validation

    Posted 08-Feb-2024 06:07

    Hello Sandra,

    I don't think there is analogue to ICH but you can look into IDEAL Framework which may help you.

    Good luck,

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
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    Original Message


  • 3.  RE: Analytical Validation

    This message was posted by a user wishing to remain anonymous
    Posted 08-Feb-2024 09:28
    This message was posted by a user wishing to remain anonymous

    Not really. There are many approaches

    https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf

    https://namsa.com/services/medical-device-testing/test-method-validation-medical-device/

    https://pacificbiolabs.com/bioburden-sterility-testing

    https://www.steris-ast.com/techtip/putting-it-to-the-test-method-validation/

    https://www.astm.org/e2782-17r22.html

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools

    https://quality-one.com/msa


    Original Message


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