IMDRF document - Application of QMS to SaMD


Inactive Registered Visitor
Not sure if everyone is aware, but the IMDRF SaMD group (which I?m also a member, representing Brazilian Industry) is creating a new document titled: Software as a Medical Device (SaMD): Applicability of Existing Quality Management System Requirements as a Risk Control Measure

The objective of the document is to identify how to apply WMS requirements (based on current ISO 13485 and related standards and regulations) to Software as Medical Device.

Right now the group just sent the draft to some specific stakeholders, and we will have a meeting in Canada at the end of January to analyze the initial comments, after that, the document will be post on the IMDRF website for public comment.

So, if anyone is interested, please keep an eye on the IMDRF website in the near future.


Thanks for the post. This is one of the areas that is getting a lot of attention and has a lot of guidance documents being generated and updated quickly. Some of the lines are very clear, but a lot still lives in the gray area.

I look forward to seeing the IMDRF approach.
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