IEC 62304, Multiple software systems in one medical device

JOQA!

Registered
Hi, I am struggeling with the software architecture and the devision between software systems and software items.
We are developing a medical device which consists of multiple parts. Hardware which includes embedded software which measures certain parameters on a patient. This hardware is able to send its data to a server and than the data can be viewed in retrospect in an online data portal. The hardware with its embedded software can be used on its own. The data portal is optional to use for the user. The hardware with its embedded software would be class C and the data portal class A. Can I say that the embedded software and the data portal are both software systems with its own class or should it be one software system and what is then the rationale why these different software items have different classess?

I hope my question is clear.
 

OccamMan

Involved In Discussions
Non-trivial issue.

In this type of situation, it’s often the case that the portal can be classified as a separate product that’s not subject to regulation as a medical device - there are several mechanisms for doing this. That’s the first thing that I’d try.

Failing that, you should be able to segregate the portal so that it’s a different classification than the embedded software. There are different ways of doing that, in part depending on how you’ll be marketing it.
 

AlexisRuiz2772

Starting to get Involved
Exactly, just declare that the online portal is not a medical device (i guess so because it only receives data)

Then i think 62304 is not mandatory for the portal.
 

Enternationalist

Involved In Discussions
This depends a lot on what these parts are doing. I'd consider them separate products. A good equivalent is to think about an MRI machine versus the program a doctor uses to view your MRIs.

Be careful with the definition of whether it is considered software as a medical device, though. If the "portal" makes (for example) interpretations of the data at hand, it may still be performing functions of a medical device.

As an example, let's say we have Product A. Product A is a heart rate monitor for high-risk patients, which sends data back to Product B. Product B is software on their doctor's computer that receives that data - and if there's an anomaly, it raises an alert for the doctor to make arrangements. That last function of Product B is really important, because it's making some clinical interpretations. Tread carefully!
 

jerryerry

Registered
Have a look at the FDA's doc "Policy for Device Software Functions and Mobile Medical Applications". It guides you through questions on how the data on the non-medical device will be used - is it crucial for diagnosis or just for data sharing etc.
 

DanMann

Quite Involved in Discussions
Exactly, just declare that the online portal is not a medical device (i guess so because it only receives data)

Then i think 62304 is not mandatory for the portal.
As long as it is only receiving and displaying data. FDA's doc and MDCG 2019-11 for the EU would guide on this.
 
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