A desperate call for help - IEC 62304 software

Hello,

I am a programmer in a small electronics company - which manufactures and developes small electronic devices for the industry. (for example controls of washing machines and all sorts of measuring devices etc.)

Over the last year we developed and programmed a control unit for a customer who now wants to sell his finished product as a medical device. (which was not intended in the first place)

The customer wants to certify his product for IEC 62304 so he demands the required documentation of our software.

Im very overwhelmed what ive read about the requirements for complying with the IEC, especially doing so after the development is finished. (note: we have no quality management system or any documentation/information system in place - i'm one of two programmers in this company who were assigned to this task)

What ive understand, is that the product of our customer has to get verified for the IEC 62304 - now i want to know what exaclty is the minimum of documentation (software wise) that we need to supply to our customer - so he can get his product IEC 62304 ready?! (by the way the product is class B) (note: we just need to hand in the documentation about our simple c code from the control unit)

and yes - we and our customer are aware of the fact that doing this after the development is already done is a "little" like cheating nonetheless it needs to be done.

If its possible - would it even be achievable for us two programmers with little to no background knowledge about project/process management to fullfill this task (development time of the software was ~6-8months) in like 2-3 months?


Thanks you in advance! and also for the forum it already helped a lot to understand the very "basics"


All the best.


tl;dr can two programmers write the documentation (software only) for the IEC 62304 (in hindsight!) with little to no background knowlegde about project/process management in like 2-3 months?

Re: A desperate call for help (IEC 62304 software only)

now i want to know what exaclty is the minimum of documentation

Click to expand...

There's no minimum documentation. Even in the amendment of IEC 62304, in which we included a step for legacy software (after I suggested this based on the solution we used for the usability standard), the legacy process is - perform a gap analysis against the deliverables of the standards and device what else you need to do.

Also, probably your client should say what he wants, not you.

Re: A desperate call for help (IEC 62304 software only)

You need to be able to establish what the safety class for the software is. That will drive your subsequent efforts.

There really aren't any novel concepts put forth in the standard, it's all pretty much basic, good software engineering. So by and large, yes, you should be able to write the documentation.

And bear in mind it's more than just providing documentation. It's a complete (cradle to grave) lifecycle management. Incumbent on you is the configuration management aspects but how will your customer gather and manage (software) issues from their customers (the end users)? All that has to be considered as part of compliance to 62304 (in other words, they can't just dump the compliance requirement on you).

I think you guys need to push back on the customer. If he wants to use the controller as part of a medical devise that's fine, but he should take ownership over all the submission file and supporting infrastructure (quality management system). He should tell you what he wants and provide guidance & templates.

Don't kid yourselves - this is not going to be a one time whack; once you venture into ongoing compliance for medical device regulation you will be accountable for more than you think.

Shimon

Re: A desperate call for help (IEC 62304 software only)

hey,

thanks guys for the input - helped us a lot!!

the current situation is that we (based on your information you guys gave us) will have a talk with our boss and our customer to define what documentation we will hand out.

it looks like not even our customer knows what he is doing or knows what he wants to have from us so ... we have to debate the whole thing again.


will keep you guys up to date. maybe there will be more questions to ask in future.

thanks a lot again!
all the best

Glad to help.
Perhaps your customer should join this forum...

Shimon