Any regulations for software availability for medical devices?

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

 

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.

 

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