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  • Medical component manufacturer and complaint handling


    I manage production and service for a medical component and device manufuacturer. Part of my role is complaints handling through our service department.

    I undestand the 13485 and FDA QSR requirements for complaints for our medical devices, but not our medical components. If a medical component is sent back to us from our OEM customer (who manufactures a medical device), does this constitute a complaint? For example - the OEM customer sends back a component we shipped them, which failed their incoming inspection. 

    Thank you! 

  • ISO 13485 for trading of medical devices

    Dears, I'm working currently in a company that export and import some medical devices (without manufacturing ), is it eligible to be certified with ISO 13485?

  • Distributor vs Supplier quality agreement

    Some of our products critical to the medical device are outsourced through the distribution chain. When discussing the Quality Agreement, do we ask for one from the distributor or the actual manufacturer?

    We sent one of the agreements to the distributor, and he answered (and, frankly, had a point) that since he is not a manufacturer, this is not a binding document, applicable to his relationship with us.

    How to deal with distributor vs manufacturer quality agreements? Who shall provide us with the quality agreement?

  • 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

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