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ISO 13485 & EU MDR - Expert Advice Community



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  • Preventive action

    Is redesigning a faulty, non-conforming product a preventive action for future products or a corrective action for the faulty one?

  • Purchase (vendors) scorecards

    Good morning,

    While working on the purchase procedure, I noticed, that the vendors scorecard is a good way to track the quality of the purchase.

    However, I dont see this particular document to be used by our company and I don't want to create anything that will not be ultimately used by my co-workers.

    Is there any other, more simple way, to comply with the ISO 13485 Purchasing but avoid the complication of a vendor scorecard?


  • Business Development and Sales - core process?

    Is it correct to place the "Business Development and Sales" under the core company's processes? For now we have it under the Management Processes, but thinking about moving it. Does is make sense?


  • GSPR

    Regarding the GSPR: is a Procedure for identification of the General safety and performance requirements needed?

  • Information about undesirable event and conducting investigation

    Could you please answer several questions:
    1) through which communication channels does the user send a message about an undesirable event to the manufacturer of the medical device?
    2) in which cases the competent authority itself conducts an investigation?

  • Difference between MIR and FSCA report

    What is the difference in MIR (Manufacturer incident report) and Report Form for FSCA?
    Is 7th revision of MEDDEV is actual today?

  • Can small start up be ISO 13485 certified?

    Is it possible for a small start up where only associates are working (in other words no employees) to be ISO 13485 certified? In addition I would like to ask you if your package ISO 13485 and MDR templates is suitable to comply also for FDA requirements for medical device

  • Risk Based Approach Document 03 13485


    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?


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