Ask HN: How to develop software as a medical device (SaMD)?

[lukko]

Hey HN!

Would be amazing if anyone can provide guidance or resources for creating a mobile app that is certified as a medical device (SaMD). In the UK, I'm aware we would need to comply with various ISO standards, notify the MHRA and complete a feasibility study to show an evidence base, but I'm finding it very difficult to map out the actual roadmap towards getting regulatory approval (e.g. FDA, CE marking, MHRA), what is necessary for compliance or finding consultancies or agencies that work in this area. Thanks so much.

[mrkeen]

Wrong country (Sweden) and possibly a competitor, so who knows if you'll be able to glean any info, but these guys are doing something like that:

https://www.vitala.health/en/home

[lukko → mrkeen]

Ah, thank you. Yep, they have gone through the regulatory process (CE-marked MDR class 1 medical device) - it is just very tricky to find what the time frame and necessary steps would be to get the regulatory approval.