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Thread: Use of Teensy in medical/IVDR devices

  1. #1
    Junior Member
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    Use of Teensy in medical/IVDR devices

    Hello,

    We've build a first prototype of an in-vitro diagnostic device using the Teensy 3.6.

    It has been working really well and we are happy with the performance, but we were wondering if it can be used in mass manufacturing of the product? And do you foresee and problems with regards to medical certification? (Both EMC and traceability).

    Thank you!

    Kind Regards,
    Louiza

  2. #2
    Senior Member crees's Avatar
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    From what I understand Medical certification like automotive certification requires a rigorous certification requiring that every component design and safety passes each of the stringent tests. We are In the process of UL and have seen some of these requirements. Every component / manufacture / facility will also need to pass stringent requirements. It’s not impossible but will not be easy. It’s best to hire a firm or consultant that specializes in this field to help facilitate and advance your product to certification with minimal issues.

  3. #3
    Depends on the device and application, "medical" is pretty broad. You'll want to pick a level of certification that suits your market.
    Is failure of your device liable (even if not likely) to cause harm to persons?

  4. #4
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    Hey!

    Thank you for your quick responses.

    The device will be classified as Class A under the IVDR and it will be used in clinic laboratories for diagnosis, so it won't actually come in contact with the end user. (It is non-invasive and non-life threatening/altering also).
    We have followed the process of developing a test plan and risk analysis in order to capture potential failure modes and mitigate against them.

    I personally don't see a reason why it could't be used but I'm just looking for some reassurance.

    Thank you.

    Kind Regards,
    Louiza

  5. #5
    Sounds sensible. For a diagnostic tool, I imagine it would be more important to quantify how accurate/reliable the tool is, and give that information to the operator for them to consider. It would then be the operators' responsibility to consider whether your tool is suitable for their purposes. You probably need some solid legal advice on how to appropriately transfer liability, or similar.

  6. #6
    Senior Member crees's Avatar
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    Edward has a good point and becomes even more broad in different countries. The only issue I see is if your regulatory authority has any PCB / component / quality requirements then it may be difficult to qualify the teensy in itself since its not certified for this kind of application. Instead you could take the Schematic and build your own custom teensy to fit your needs and any regulatory requirements.

    This site has an interesting read. Only applicable if you plan to use in the USA.

    https://www.tempoautomation.com/blog...b-development/

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