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  • Can contract manufacturer exclude validation from their scope?

    I just want to know if it is possible that a contract manufacturer can exclude validation from their scope?

  • Preparing site for first-time ISO 13485 audit

    How to prepare the site for the first-time audit for on 1ISO 13485?

  • Guidelines for complying with ISO 13485 regarding validation and computerized system validation

    What guideline do you recommend to use to comply with ISO 13485 regarding validation and computerized system validation. We will not need to comply with FDA guidelines. Please share any recommendation.

  • Calibrating instruments after due date by fixing the window period

    I have one doubt, can I calibrate the instruments after the due date like by fixing the window period. Is it acceptable?
    Example: Calibration due date is 10 September. the window is 5th to 15th September, can I calibrated 12th September after the due date.

  • ISO 13485 workflow explanation

    I want to get detailed explanation of workflow of ISO-13485 which i have .I am not able to explain it to my manager how this ISO works from beginning to end step-wise like starting from section 4 to section 8.

  • ISO 13485 Lead Auditor

    1. Is it possible for An ISO9001:2015 auditor to audit Medical Devie manufacturer?
    2. How can I qualify myself on ISO13483

  • Differences between EU MDR and US FDA regulations

    What are the differences between EU MDR and US FDA regulations?

  • Procedure(s) for conformity assessment

    I hope you are doing well. I am browsing through some of the documents in the EUMDR kit I bought a while back, I don't see procedure(s) for conformity assessment.
    would you please point me to the right direction for a conformity assessment procedure.

  • Strategy to assess if the change is a significant change

    Could you tell me what the strategy is to assess if the change is a significant change?  Perhaps I’m not searching using the correct wording.  Any chances that the documentation would refer to the “NBOG’s Best Practice Guide 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System”?

  • Main challenge stat up companies face to comply with ISO 13485

    What is the main challenge stat up companies face to comply with ISO13485?

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