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Any regulations for software availability for medical devices?

Discussion in 'Other Medical Device Regulations World-Wide' started by Csongor, Aug 2, 2019.

  1. Csongor

    Csongor New Member

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    Hi all,

    This is my first post on this forum, thank you in advance for having me.

    We are manufacturing a medical device and designed a software to pull the data from it to a PC. Are there any regulations regarding the availability of the software: must it be included in a CD/USB stick in the package or a secure link to download it is always enough?

    Thank you for any guidance and Best regards,
    Csongor
     
  2. yodon

    yodon Well-Known Member

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    A bit tough to answer given the limited information.

    Is the software considered part of the device or possibly a device in and of itself (SaMD)?

    Either method of delivery is acceptable but there should be checks to ensure the install is correct.

    Side note: if you're transferring any protected health information, be sure to, well, protect it! GDPR violations can result in some sizeable fines.
     
  3. Csongor

    Csongor New Member

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    Hi Yodon,

    Thank you for the prompt reply. The software is considered a separate medical device, although without it the device data cannot be imported and used at all.

    I was not sure that it is alright to assume that the user will have internet connection for downloading - I was sure that there are some regulations that protect the users who are without internet connection.

    Thanks for the tip, we are paying attention to that!

    Best regards,
    Csongor