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ISO 13485 & EU MDR - Expert Advice Community

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  • Risk Based Approach Document 03 13485

    Hello 

    I had my stage 1 audit, which went well.  I had a minor non conformity on the quality manual.  Document 03_Quality_Manual.  

    The non conformity was as follows:  the quality management requirements are not fully inplemented because it was not made clear in the quality manual which process apply risk based approach.  

    This was in reference to 4.1.2.

    But the quality manual template does not reference a risk based approach.  The only time in document 03 that risk is mentioned is under section 7 for product realization.

  • MDR/ISO 13485 risk management of "SYSTEM"

    Our company manufactures system (of products) as defined by MDR 745/2017 definition ( "system’ means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose"). I would like to know if the risk analysis, clinical evaluation and post market surveillance is done for the whole system or its individual parts. Thank you.
  • Which ISO standards are mandatory to purchase as an official version?

    I would like to find out which ISO standards are mandatory to purchase when implementing ISO 13485. There are many different ones, and quite frankly, expensive. I understand that ISO 13485 or ISO 14971 /24971 must be purchased as an official version, but what about others?

    Thanks.

  • 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?

  • ISO 13485/MDR certification

     We are preparing for the certification according to ISO 13485 and MDR.  Our company has 14 meddev families. Is it possible to limit the scope of the certification on 2 families only or we HAVE to have all 14 families covered (risk file, tech file, etc)? So technically we would use the CE mark on two products initally and move forward.

  • Device classification map (questionnaire) for MD/IVD

    I'd like to know if we need, for the certification puroposes, a filled device classification map (questionnaire) or if the result of classification is enough? In order words, is the chosen MD class enough or we need to show how we got to the specific MDR/IVDR class?

    To clarify bit more: we used an online software to classify the MD. We got the result, but not the path with questions and answers.

    Thank you,

    L.

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