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Hi everybody,
We have a simple medical device where small electric currents are generated.
Due to the nature of the device, delivering electric currents to a user, it's possible to cause skin irritation when used incorrectly. The software embedded in the device actively prevents this.
The way I read the IEC 62304 software classifications ANY injury (irritation/brusing/burns/etc) will cause the system be class B. So when the software has a runaway process the safety features could not function properly. I prefer not to have to write all the class B documentation. So I would like to classify the device as Class A.
I was wondering if a hardware watchdog (either internal to the MCU or external hardware) would be sufficient to guarantee that the software is properly running with the software safety measure active (not a runaway process), and thus allowing for Class A.
Any ideas if this would be acceptable?
We have a simple medical device where small electric currents are generated.
Due to the nature of the device, delivering electric currents to a user, it's possible to cause skin irritation when used incorrectly. The software embedded in the device actively prevents this.
The way I read the IEC 62304 software classifications ANY injury (irritation/brusing/burns/etc) will cause the system be class B. So when the software has a runaway process the safety features could not function properly. I prefer not to have to write all the class B documentation. So I would like to classify the device as Class A.
I was wondering if a hardware watchdog (either internal to the MCU or external hardware) would be sufficient to guarantee that the software is properly running with the software safety measure active (not a runaway process), and thus allowing for Class A.
Any ideas if this would be acceptable?