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ISO 13485 & EU MDR - Expert Advice Community

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  • Lateral flow device

    i am trying to find out what a lateral flow device using saliva would come under with the FDA class 1 or class 2
  • Calling organization's products after certified ISO 13485 QMS in place

    With a certified ISO 13485 QMS in place  which is in alignment to national regulatory body as well (though not audited by national regulatory body), can an organization call its products:
    1. GMP grade products or
    2. ISO13485 conforming products or
    3. ISO 13485 and GMP conforming products
    Note: I have not used the word compliant for GMP since as I understand that the organization needs to be audited by regulatory body to claim the same?
  • 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?  
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