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ISO 13485 & EU MDR - Expert Advice Community

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  • Supplier to a medical device company

    We supply components to medical device companies but actually do not make a medical device.  We are ISO 13485 because we choice to be not because we had to be.  Are we required to maintain a Medical Device File?

  • Is ISO 13485 for fertility company?

    I manage a Research and Development lab for a women’s fertility company. We develop kits and assays for genetic testing but we do not manufacture anything in our lab specifically. Would ISO 13485 be the right option for us?

  • Responsibilities of Distributors for collection of Medical Devices and incident reporting

    Responsibilities of Distributors for the collection of Medical Devices and incident reporting

  • Do medical device distributors and 3rd party logistics providers benefit from implementing ISO 13485 and MRD?

    We are a 3PL. I understand that the ISO 13485 regulations were designed specifically for Medical Device manufacturers. However, do medical device distributors and 3rd party logistics providers benefit from implementing these standards? Additionally, can 3PLs be certified under ISO 13485?

  • Implementation, Compliance software, Training

    Hello, we are a research lab and are looking at setting up a diagnostics lab to make 2 of our tests available (plus NHS are interested in using them).
    We need to get the lab ISO 15189 accredited but for the tests we perform, do we also need to be ISO13485 accredited?
    For one of the tests we supply a urine collection kit. If we are to send the kit to patients for sample collection do we need to be accredited (ISO13485)?
    The company we purchase the sample collection vessel from, are already ISO13485 accredited.
    We receive the sample from the patient and then perform analysis on it so is the extraction and instrument analysis kits regarded as medical devices?
    I'm a little confused so any help would be great

  • Change management

    we are being evaluated as a potential supplier. The customer provided us with an extensive questionnaire.

    An entire section is related to change management. From what I understand, the change management as such is not part of ISO 13485.

    I believe it is an FDA requirement.

    How should I answer the questions related to the change management without losing the trust of the customer?

    Or should I just create a new procedure?

  • Advanced notification of change

    What should be a typical timeframe for advance notification of change to our customers?

  • 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?

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