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ISO 13485 & EU MDR - Expert Advice Community

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  • External auditor for contamination for warehouse environment

    my interest is what does an external auditor look for contamination for warehouse environment

  • MDR Device Labelling

    Hello I have a query.  A European manufacturer I use is transitioning to MDR.  They have now included RX only on the label.  This is to satisfy the FDA requirements.  But it is not a UK or EU requirement.  Should this be displayed on the label we sell in the UK and EU? I think it will cause issues. But I am unsure. thanks

  • Gxp versus 13485

    I am working an a pharma company with haveing a some combination products - medical device with pharma. We want to have in addition to GxP System the 13485.
    Could we implent the 13485 with a mixture of good running GxP SOP (e.g. change control) and new ISO SOP?s

  • Measuring Equipment

    Hello,

    is the definition of the measuring equipment in ISO 9000 applicable for ISO 13485?

    “Measuring equipment” is defined in ISO 9000 as “measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process”.

    Could you elaborate on what type of equipment we must take in consideration during the implementation process?

    Thanks.

     

  • Matrix of Key Performance Indicators

    Is the Matrix of Key Performance Indicators from Procedure set 23 different for every Management Review, or is it a set of all KPIs in general?

  • Customer complaint - reporting to the authorities

    Would it make sense to move the Registry of Reports to the Authorities from section 08 Customer Complaints and Feedback to 15 Non-conformities? Or make a connection in the procedure between the Report to the Authorities and 15 Non-conformities section?

    I am still unsure which complaints/non – conformities/ adverse events we should report.

    I understand that a complaint can result in non-conformity, and non-conformity could result in some adverse event.

    Do I see it correctly?

  • Is ISO 13485 certification applicable for company which provides eQMS dedicated to medical device industry clients?

    I'd like to know if ISO 13485 certification is applicable for our company which provides an eQMS dedicated to the medical device industry clients, though our eQMS is not a medical device

  • MDR 2017/745

    I have my own company in ***. I buy glasses frames and sunglasses from a factory. The factory just send me a Declaration of Conformity of Optical Frames which says that they meet the MDR 2017/745. What does that mean for me? What do I have to do?
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