Working AI platform for medical device regulatory gap analysis — seeking IND-03 consortium

Most AI-for-regulatory proposals promise a platform that will be built during the project. We already have one in production.

Klaris AI is a London-based MedTech startup focused on one problem: medical device companies spend months and hundreds of thousands of euros on regulatory documentation that still comes back with gaps. Our platform uses AI trained on device-specific regulatory frameworks to automate gap analysis in technical documentation.

For a consortium targeting IND-03, we offer something specific: a working AI system that can serve as the testbed for validating improved regulatory methodologies and evidence frameworks across the device lifecycle. This means the consortium can demonstrate real-world applicability from day one rather than spending the first 18 months on platform development.