While the overall process is for the most part the same, there are several considerations during AI/ML algorithm implementation so it's probably a good idea to include additional detail, especially around data management for algorithm training, testing and validation.
If I remember there are a few guidance documents and standards being developed that address specific requirements around design and development process of AI/ML, but don't remember specific references.
Here's one I have handy that provides some guidance:
https://github.com/johner-institut/ai-guideline/blob/master/Guideline-AI-Medical-Devices_EN.md------------------------------
Michael Zagorski RAC
Director of Regulatory Affairs
Pittsburgh PA
------------------------------
Original Message:
Sent: 22-Jul-2021 02:57
From: Ella Sheiman
Subject: AI/ML integration into the SW development procedure
Good morning everybody!
Do you add any parts into a software development procedure that is based on IEC 62304 to cover AI/ML?
My understanding is that the development process is the same but was not sure if there are specific parts that need to be integrated to cover it better.
Thank you in advance
Ella
------------------------------
Ella Sheiman
Haifa
Israel
------------------------------