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IEC 62304 Applicability - GUI Control Software

#1
Hi all,

I work for a small medical device development firm, and we are designing an analog device to provide a medical treatment. We have been a bit stymied by IEC 62304.

The device output is controlled in an entirely analog manner. We are considering using a touchscreen GUI to initiate treatment, (essentially act as a switch), and report errors from the device (e.g. over temperature). The GUI would not have any control over treatment other than to start/ stop it.

In this scenario, does the software involved still classify as "Software that is a component and integral part of a medical device"? Is 62304 applicable?

Any insight you can provide is appreciated!
 

yodon

Staff member
Super Moderator
#2
If the software is used with the device / part of the device, I think you'd be hard pressed to justify why 62304 is NOT applicable. The standard does allow you to classify the software based on risk so if, indeed, it only acts as a switch then I would think you' be justified in managing the software as Class A - which is fairly light-weight (and frankly, aligns with basic good software engineering practices).

That said, you do indicate that errors are reported (over temp). That may push the classification higher if those controls prevent harm. If an overtemp condition is detected, does the software initiate any actions (e.g., shut down)?
 

robert.beck

Involved In Discussions
#3
Whether the IEC 62304 standard applies or not, it contains a lot of good software development and testing practices. Whether it applies or not to your product depends on the device's regulatory classification and jurisdiction. For instance, FDA accepts IEC 62304 as a recognized consensus standard but only in that adherence to the standard supports an assessment that the 'software development environment' is appropriate and meets FDA's Quality System Regulations. If your device has or will have CE Marking, then some level of adherence to this standard is advisable. As Yodon advises, you should perform a risk assessment on the device and the software to determine what IEC 62304 refers to as the "software safety classification."
 

glork98

Involved In Discussions
#4
In this scenario, does the software involved still classify as "Software that is a component and integral part of a medical device"? Is 62304 applicable?
Yes.

Get it and read it. Then determine the classification. Ask at least these four questions:

What happens if the device does not turn ON when needed?
What happens if the device does not turn OFF when needed?
What happens if the device turns ON unexpectedly?
What happens if the device turns OFF unexpectedly?

Tip: The answer can't be to challenge the question.
 
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