Does BLE sniffer with correspond SW has the ISO9001?

Question

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 · Accepted Answer

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.

Does BLE sniffer with correspond SW has the ISO9001?

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