Hello Anon,
This can be quite involved with a change process to a product, though it is allowed and done. However, this needs to be managed as any other change control process to a medical device. Even if the software version is "pushed" or automatically done, the user might need to be informed and there needs to be a way they can review the release notes with dates to know exactly what was changed and when. This highly depends on the software application - as an example - if this is a diary for monitoring something maybe not too strong, but an imaging software for cancer might need much more control. It also depends on your customer base and how they are using the software such as if they do their own quality control or verification for the use of the software. If there are changes it may impact how they are using the software in their own processes.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 19-Apr-2024 10:49
From: Anonymous Member
Subject: SaMD and Pushed Software Patches & Updates
This message was posted by a user wishing to remain anonymous
Hello,
I am curious if anyone has any experience with Medical Device Software and pushed or automatic updates and patches. It seems that with the release of the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance in September of 2023 the FDA is encouraging pushed or automatic updates and patches (see proposed cyber metrics and Section 2c) in devices. Does anyone have experience pushing updates and patches to the field on a Medical Device? If you switched to this model were customers accepting of the change? What challenges have you experienced?