Regulatory compliance for Software as a Medical Device is hard. The rules are dense, the frameworks differ by jurisdiction, and the cost of getting it wrong (delayed launches, failed audits, wasted development cycles) falls hardest on the teams least equipped to absorb it.

Regi was built to change that.

We're a regulatory intelligence platform purpose-built for SaMD and AI-enabled medical technologies. We help product teams, founders, and compliance leads understand exactly what's required to bring a device to market (across the FDA, EU MDR, and UKCA frameworks) without needing a full regulatory affairs function in-house.

We work with teams from early-stage product development through to post-market compliance across multiple jurisdictions.

We're built around the core belief that regulatory clarity shouldn't be a competitive advantage available only to large, well-resourced organisations.

If you're building in digital-native health or AI-enabled care- and you're trying to move faster without cutting corners- Regi is for you.


Regi

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Regi

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