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Required Checklist Showing Compliance to IEC 62304

#1
We have a TUV auditor (EU) here inspecting our software development, and he has stated that we need to show compliance with 62304 in a "formal report" or "checklist", otherwise we will receive a major non-conformance. Does anyone know why this is required for 62304 specifically and where the requirement is stated?
 
#2
Because it has been harmonized with the Medical Device Directive in the EU and recognized as a Consensus Standard by the FDA in the US.
Now, IEC 62304 can be used as a benchmark to comply with regulatory requirements in both markets.
 

Marc

Captain Nice
Staff member
Admin
#4
Because it has been harmonized with the Medical Device Directive in the EU and recognized as a Consensus Standard by the FDA in the US.
Now, IEC 62304 can be used as a benchmark to comply with regulatory requirements in both markets.
I think the question is: Where is the requirement specifically stated.
 

yodon

Staff member
Super Moderator
#5
If you are citing 62304 as a means to meet the applicable requirements, they want to see the evidence. I ran into this with a different NB and they said I had to either get a certified lab to do the assessment (checklist / verify compliance) or they could do it at a greater cost (and protracted review time).

If your device has to meet 60601-1 requirements, that's kind of built in - test labs I've been working with have requested we complete a 62304 checklist, they then verify, and assert compliance in the formal report. The NBs have accepted this without blinking.

I've seen other NBs accept the checklist compiled by the manufacturer. Given the choices, I'd prefer to complete the checklist myself. :)
 

yodon

Staff member
Super Moderator
#7
The test lab provided one checklist but, yes, pretty much clause-by-clause. They broke it out into process checks (where are your documented 'SOP-level' procedures for the required processes; e.g., where do you say you do planning) and application checks (e.g., where is the plan that complies with your procedures and the standard).
 
#8
Please note that the MDD is not very clear on this, but the MDR is very clear that you need to to show compliance if you choose to gain presumption of conformity with an harmonized standard (and also for any other verification activity), so this will also apply to things like ISO 14971, ISO 10993 and other "process" standards.
 

primavesvera

Starting to get Involved
#9
We had a similar issue with our NB. They charge for the evaluation of the IEC 62304 and I didn't really understand what they want to see exactly since it is a process-based standard. However, they told us that they will compare our documents with their checklist based on IEC 62304, so I decided to go one step ahead and insert the checklist at the beginning of our lifecycle documentation.

It is an overview of the clauses that are applicable for our class of the software and I connected clauses with our procedures and related processes.
 

Tidge

Involved In Discussions
#10
Similar to yodon and primavesvera, I've seen a clause-by-clause table/checklist contained within software development policy document that identifies how the company's process is fulfilling the elements of 62304. For the company I was most familiar with, this 'checklist' was at the back of the policy as an appendix. There were never any problems on this score with either Notified Bodies or Testing Laboratories.
 
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