ISO 13485 & EU MDR - Expert Advice Community

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  • Risk Management and FMEA

    I am working on completion of our Risk Management Procedures. Is FMEA required for Class I devices, or is there a simpler alternative we can use?

     

  • Examples of Applicable regulatory requirements

    What are examples of Applicable regulatory requirements?

  • Does ISO 13485 cover code required electrical and fire approval such as UL?

    Does ISO 13485 cover code required electrical and fire approval such as UL or is this just medical approval?

  • ISO 13485 / MDR

    1. Clinical evaluation - are we qualified to complete this ourselves? I have documented professional experience of >14 years but not a medical degree
    2. MDR requires a suitably qualified person to act as the person responsible for regulatory affairs - is there any definition about what suitably qualified means?

  • Technical file and clinical evaluation

    With the combined package for ISO 13485 and MDR, do we need any external assistance with the technical file and clinical evaluation? i.e. a healthcare professional

  • Language requirements on medical device class 1 products

    1. What language requirements are there on the following in countries within EU?

    • Labels of main product
    • Labels of product boxes
    • Labels of outer boxes
    • Manuals/IFU

    2. Do you have a list on specific language requirements PER country on the above?

  • Biggest challenge when seeking EU MDR compliance

    What is the biggest challenge when seeking compliance to the EU MDR?

  • List of ISO Standards for medical devices and IVD’s

    Is there a list available with all the ISO Standards for medical devices and IVD’s?

     

  • Mock recall in medical devices

    I was looking for information regarding Mock recall in medical devices UK & EU under ISO 9001 & ISO 13485

  • Complying with ISO 14971

    As part of the ISO 13485, do we also need to comply with ISO 14971?

     

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