R
RickQualityGuy
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.
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.