Hi Andy
If the massive initial capital requirement is an issue, you can always go for an already certified module. There are many out there, but BR-LE4.0-S2 is an example from Blue Radios. Its Basically a CC2540 with antenna and can around it, and is already certified. Might even be useful in getting your product to market sooner until you can sort out certification of your own module. They are substantially more expensive though.
Regards
Tielman
