IEC 62304 Compliance - How is compliance to IEC 62304 verified?

R

RickQualityGuy

#11
Very inciteful. Thank you John. The only thing I would add to this is the MANUFACTURERS are our customers so anything we can do to make their lives easier in terms of how they must "risk manage" us, we would certainly want to do if it's within reason. Thanks again.
 
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J

JSambrook

#12
I absolutely agree that you should do all that you can to make it a "no brainer" to design in your product. If that means simplifying someone else's life in terms of compliance, it's probably worth your company's time to do it.

Best,
 

Peter Selvey

Staff member
Super Moderator
#13
As already said, 62304 is a standard that "legally" applies to the manufacturer of the actual medical device. Also there are many decisions that can only be made from the point of view of the medical device (e.g. software classification, risk management etc).

However, in your situation it makes sense to use certain assumptions and try to prepare for 62304 as much as possible.

Then you can make a document which declares these assumptions and also says which parts of 62304 you meet. You can give this document to your clients when they ask about 62304.

Be careful not to claim that you "comply with IEC 62304", only the manufacturer of the medical device can do this.
 

kreid

Involved In Discussions
#14
To offer an alternative view point:
In a sense you are right when you say is it like ISO9001 in getting a 3rd party auditor to verify it. Like ISO9001 you would set up you processes to be compliant with 62304 - this is the first step. Then you get your processes validated with respect to 62304. In your case you could get your customer to do this validation - then they can say to FDA or CE that their outsourced software has been developed iaw IEC 62304 and demonstrate this with an audit report.

This I think is the tidiest solution for your particular situation.

Obviously there are other issues to think about - who bears the cost of changing your development processes; was it specified in the contract that you meet 62304; could you develop new income streams if your processes were aligned to 62304 etc etc
 
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