Any sample of a full software life cycle IEC 62304 report ( any class )?

yodon

Leader
Super Moderator
Not completely sure what you're asking. What is a 62304 report? Are you considering an audit (report) of the software lifecycle? Are you asking about 5.8.6 in t2304 (ensure activities and tasks are complete)? Please clarify.
 

yodon

Leader
Super Moderator
There is a checklist that is developed from the standard. That is required for submission to our NB for CE Mark review
There isn't a standard published checklist. If you submit your device for 60601-1 testing, the test lab will give you a checklist to complete. It just walks through the standard, clause-by-clause and asks you to provide evidence that your processes address the standard and that you have developed the required deliverables. It's been my experience that if you don't have a test lab do the assessment, the NB will charge extra to assess compliance to 62304 but they didn't indicate they used a checklist.
 

Tidge

Trusted Information Resource
I don't specifically recall that our NRTL (used for 60601-1 certification) that we sent an ME device (with software) had the software deliverables on a checklist... but I had mostly disengaged from the project at that point. I have very strong recollections of the 60601-1 checklist, but nothing on 62304.

I feel obligated to disclose that our software development process is 100% aligned with 62304, and so we could have trivially completed a 62304 checklist by walking down our (internal) software development plan and report... which can partially explain why I have no memory of this. Our NBs have reviewed our software development process; I've no doubt that they looked at some actual deliverable as a cross-check. The deliverables for 62304 are rather closely aligned with the (quite well-established) FDA deliverables based on the FDA's Level-of-Concern, so these are the sorts of things that are routine (for us) to find and provide. If you have done an FDA submission it should be rather straightforward to identify artifacts.
 
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