Your regulatory approach seems well researched. Nice job on that! Most people underestimate how much time and effort it takes to get a medical device certified. Launching as a non-medical device first, getting some feel for PMF and then expanding the claims is the smart way to go.
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):
Why am I not surprised? ;) Open Regulatory is doing great work, the founder is a fantastic guy. A breath of fresh air in the opaque and boring regulatory world.
