ISO 13485 & EU MDR - Expert Advice Community

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  • Guideline on oxygen tank calibration

    Need your help to tell me is there a guideline on the oxygen tank?calibration?

  • Clinical Evaluation

    Which area of ISO 13485 covers or fits the Clinical Evaluation part? Is it only in "7.3.7 Design and development validation"?

  • Are Cardiovascular Stent covered in ISO 13485?

    Are Cardiovascular Stent covered in ISO 13485?

  • Difference between EU manufacturer's distributor and (transport) service provider

    What is the difference between an EU manufacturer's distributor and a (transport) service provider? Does the distributor have to do the installation too?

  • Calibration SOP

    HI, I'm trying to find out if I need a calibration SOP for Design Controls. Since V&V are part of Design Controls, I would think that a calibration SOP has to be in place to ensure that a verification or validation is valid when using equipment that requires calibration. Any thoughts?.

  • Obtaining CE Mark

    Can a product owner who does not own ISO13485 but manufacturer has its ISO13485 apply and obtain CE marking for medical device product"

  • Importer and Distributor obligations under MDR

    We will be working with importers / distributors for our product. Possibly we will be importer or distributor ourselves for some products in future.

    When checking MDR obligations for economic operators they should (amongst other obligations) perform a verification of medical devices they handle.

    I have clear what needs to be documented for the verification but what I do not have clear is whether this verification obligation applies

    • to devices that ere CE-marked under MDD and MDR or
    • to devices that are CE marked under MDR only 

    I highly appreciate your help, best regards,

  • Understanding requirements for company providing technical services

    Need to understand the requirements for a company providing technical services, including technical writing, for a medical device company.

  • Which clause should I refer for supplier qualification?

    Can I know which clause should I refer for supplier qualification?
    for ISO 13485: 2016 - Is it 7.4.2 (c)?

  • Sub clause Explanation

    1. In which clause does the recording of FPA approval , Daily check sheets, Recording of clean room temperature comes under?? 2. Under which clause does the naming (Document number , Rev no , Date ) for a format comes ??
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