IEC 62304 - Medical Device Wi-Fi Radio Requirements

R

RickQualityGuy

#1
The company I work for designs wi-fi radios that we sell to a broad spectrum of customers. Some of these customers manufacture medical devices such as IV Infusion Pumps which our Wi-Fi radios are inserted into as a sub-componet. Our Wi-Fi radios have software embedded in them such as driver code and radio configuration utilities.

My question is should we be compliant with IEC 62304 in this context and/or should our medical device manufactuer customers expect us to be compliant?

Also, what would be the consensus be for the risk classification for this type of application:

Class A - minor effect after failure
Class B - moderate effect after failure
Class C - severe risk after failure

Thank you very much.
 
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c.mitch

Quite Involved in Discussions
#3
Hi,

If I understand your message, your company isn't a manufacturer of MD and as such isn't subject neither to MD regulations, nor to standards like 62304.

-->My question is should we be compliant with IEC 62304 in this context
Yes, you may, on a voluntary basis. for your company this will be a marketing advantage compared to your competitors.

-->and/or should our medical device manufactuer customers expect us to be compliant?
Yes, they may ask you to be compliant. Again, it may be a good argument to say "yes, we are compiliant" to win a contract.


-->Also, what would be the consensus be for the risk classification for this type of application
We can't answer this question. It depends on too many factors.
I'd rather say it's the responsibility of your customers to assess the software safety class.

FYI I've seen components manufacturers declaring their components are developped with class C, to be able to answer any quote requested by their customers.

Cheers

Mitch.
 
M

MIREGMGR

#4
I agree with C.Mitch's comments.

(...) risk classification for this type of application
The risk classification for a component depends on that of the device in which it is used, therefore is not a function of the component per se.

In the described application, malfunction of an infusion pump in some contexts could result in death. The particular range of applications of your customer's infusion pumps might be limited so that such a risk level would not apply, though.
 
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