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ISO 13485 & EU MDR - Expert Advice Community

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  • 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?

  • Clean room requirements standards for ISO 13485:2016

    What are the cleanroom requirements standards for ISO13485:2016?

  • Documents required by MDSAP and FDA in ISO 13485 Documentation Toolkit

    1. Do you have in your 13485 & MDR package documents required by MDSAP? If no, where I can get them. 2. The same question about your 13485 & MDR package documents required by FDA?"

  • Documented checklist for SaMD

    I have started worked with software base medical device company , i have to implement ISO 13485 for SaMD and i am new for software base medical device work , can you help me for documented checklist for SaMD

  • Preparing Medical Device File

    I like to prepare a medical device file from initial as i have starting manufacturing the medical device so please help me!!
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