In order to bring a CGM to market, in many areas of the world you need to perform a number of clinical trials, and a certain MARD upper bound has to be demonstr

In order to bring a CGM to market, in many areas of the world you need to perform a number of clinical trials, and a certain MARD upper bound has to be demonstrated. Also, during development certain ISO/IEC standards must be followed, which cover continuous medical & information risk assessment and mitigation. It’s usually a process of up to a few years even after you have a strong belief that it performs well enough.