ISO 13485 & EU MDR - Expert Advice Community

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  • 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?  
  • Replacement for Directive 93/42/EEC

    According to MDR 2017/745 - which kind of certification will replace Directive 93/42/EEC?
  • Training in the company

    I would like to check with on actual process for Training in company.What are documents required and who will be the people responsible.

     

  • Symbol MD in the label of Medical Devices Class I (no sterile)

    Hello,   from today on, to be compliant with the new EU MDR, the production of Medical Devices Class I (non sterille), needs to have the MD symbol in the label?   Thank you, Isabel Sottomayor
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