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

Y

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.
 
Y

yodon

Leader
Super Moderator
AMW02053NOV said:
There is a checklist that is developed from the standard. That is required for submission to our NB for CE Mark review
Click to expand...
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.
 
T

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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