Artifakt Medical is an AI-native regulatory consultancy for medical device manufacturers working under EU MDR and ISO 13485
Artifakt Medical is an AI-native regulatory consultancy for medical device manufacturers working under EU MDR and ISO 13485. We help manufacturers bring compliant products to market and keep them compliant once they're there, without the time and cost unpredictability that regulatory work usually carries. We work especially with startups and scale-ups building software and AI devices. The difference is in how the work gets done. We pair hands-on industry regulatory experience with deep technical and AI expertise, so the hard judgment calls get expert attention while the document-heavy work gets faster and more consistent. That same approach runs through the tools we build. Our first product, Artifakt Vigilance, is live and free during launch. It turns post-market surveillance from a recurring burden into a structured, repeatable process: a documented literature and vigilance-data search across eight safety databases, generating a PRISMA / MEDDEV 2.7/1 literature review report. Try it at vigilance.artifaktmedical.com. Further tooling across the technical documentation lifecycle is in active development alongside our manufacturing partners. Because we put AI to work on regulatory and design data, security is built in from the start, not added afterwards. What we build is EU-hosted and isolated per client. The manufacturers we work with cannot compromise on the confidentiality of that data, and neither do we. Get in touch to talk through where your compliance work is slowing you down.