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ISO 13485 & EU MDR - Expert Advice Community



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  • Measuring Equipment


    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?



  • 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?

  • Procedure for Design documentation management for medical devices

    Do you have separate procedure for "Design documentation management for medical devices"?  I mean how to execute drawings, Bill of materials, schemes electrical and so on? Thanks

  • CE Mark

    We would like to inquire after regulations / requirements needed for a patient controlled analgesia pump. Is there a guideline that needs to be followed or adhered to in order to get the CE mark on a product?

  • Equipment Qualification vs. Process Qualification and Process Validation

    I am trying to get a better understanding about the guidance on Equipment Qualification vs. Process Qualification and Process Validation. Can you refer me to the sections of the standard that speak about those topics?

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