Yes! Thank you. I feel like some companies can slip into medical device territory to avoid all the hassle..

Honestly the regulatory process I have found to be incredibly opaque and difficult. It's tricky to find out what exactly qualifies as a medical device, and then the process for certification. A company called Open Regulatory helped us and the flow chart here is helpful (for UK):

https://www.gov.uk/government/publications/software-and-arti...