Does BLE sniffer with correspond SW has the ISO9001?

[VadymS]

In our company developing medical devices only tool with ISO9001 can be used. Does the ISO9001 quality standard cover BLE sniffer with correspond SW?

[awneil]

Yes, I was also getting that - but now it seems to be fixed for me!

[Joakim Jakobsen]

This should be fixed now.

[awneil]

You need to distinguish between things that are used purely for "indication", and things which are used for measurement.

For measurements & things that your design relies upon, you need things to be properly calibrated, etc.

For indication, you don't.

Your Quality Manual should have procedures on this.

I would strongly suspect that the BLE sniffer falls into the "for indication only" category.