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One function, many devices? IEC 62304 and Medical Device Imaging Software

S

SayDo

#1
Hi! I'm a first time "poster" and I'd like to first of all thank everyone in this forum - there is some really great stuff posted here!

I've just been hired into a software development company that develops common filter and image enhancement software libraries for use in a variety of medical imaging equipment.

We want this software to be IEC62304 compliant to reduce any obstacles our clients may have in wanting to adopt our technology.

But when I read IEC62304, I'm confused because it seems to apply to software that is being developed as part of a development program for a single medical device.

And since out software is intended for medical devices, it doesn't fit the definition of SOUP.

Does IEC62304 apply to this kind of software?:confused:
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Does anyone here have any ideas or help for this one? My Thanks in advance!
 

glork98

Involved In Discussions
#3
One issue is how your customers choose to view your software. They can consider it SOUP in which case they need to test it and place appropriate hazard mitigation strategies around it. If you develop to the standard then your customers will find it more valuable. ($$$)

You can view your product as the library. Something to determine is the class of your software and the class of the final products it will be put in. No safety hazard, or "Class A," under 62304 is roughly nothing in term of process requirements. OK, I'm exaggerating but only a bit. If you want to be "B" (patient and operator safety critical) you'll be valuable to customers making most medical devices.

I don't think you're library will be involved in life supporting products (Class "C") but it's a fairly small step to that from "B."
 

Marcelo

Inactive Registered Visitor
#4
Hello Saydo and welcome to the Cove!

IEC 62304 is for embedded software and also for software which is a medical device in itself (which seem to be the case of yours).

MEDICAL DEVICE SOFTWARE
SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right

Even if this wasn´t the case, IEC 62304 does provide a general framework for software that medical device/healthcare software developers could use if needed. People sometimes are too worried about the bureocratic nature of standards (for example, the scope or being applicable or not) that they sometimes forget that standards are nothing more than collections of information from the literature and best practices :)
 
Last edited:

Marcelo

Inactive Registered Visitor
#6
Can you explain how those standards apply? One is usability and the other is nuclear-specific.
Woops, my mistake.

It should be

"IEC 62304 is for embedded software and also for software which is a medical device in itself (which seem to be the case of yours)."

Thanks!

Er..didn´t understand what you said about nuclear-specific.
 
S

SayDo

#8
Thanks! THese are good things to think about.

When we started, we didn't sweat the scope (are we medical device or SOUP) of IEC62304 so much. We did our development as close to IEC practices as we could. But, there were obvious limitations - we can't do a full risk analysis because our "libraries" must be managed by the software that the manufacturer develops, we don't know all the intended uses of their products, etc. We figured Class B was appropriate for us.

Its just that now, we want to claim compliance but... the "lifecycle" causes some issues. Our technology is produced far in advance of its use in a medical device. We perceive that the manufacturer may consider us "SOUP", but we want to lessen that burden - this is where we add value!

SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE...
And - yes, our software is intended to be embedded in a medical device, but we don't know which one!

Sooo... Can we claim compliance? Will the Medical Device manufacturer be able to claim compliance if they use our software and don't consider it SOUP?
 

glork98

Involved In Discussions
#9
Actually you can do a risk analysis. In it you would identify mitigation actions that the user needs to take.

If you have artifacts that demonstrate that you developed the code in compliance with 62034 then your customers won't need to call your code SOUP and do other analysis and risk mitigation around your code. This is actually harder than it sounds as, I believe, your company should be audited for compliance.

Perhaps a path is to supply all your design docs, source code and test code to the customers and let them include it in their development process. They don't write anything but they review, compile, test and control the code themselves. High buck RTOSes take this route.
 

sagai

Quite Involved in Discussions
#10
I would argue a bit, sorry, from the Customer prospective, I believe it will be a SOUP/OTS to validate prior to build in the Customer's finished medical device as long as it had researched and developed in a separate QMS.
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