Bluetooth pairing + FDA

I am using some Bluetooth modules and it is important that the devices are paired uniquely. The product needs to meet all the regulatory requirements for the FDA and I was told by a friend that they will not allow pairing of devices based off a software key. My understanding was that there had to be a hardware key (dongle, sdcard) or something on the device to be sure there are not mistakes with pairing.

Do you guys have any ideas on this? How are medical device companies doing this?

Also how many devices should I be able to connect up to the monitoring device? Is each device on its own channel? How is the data read from all these channels? Any information on this would be great.

Thanks.

- Dutchman

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dutchman
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