Author name: klinik_ai_dev

CE marked medical AI
Onboarding Support

What CE Marking for a Medical AI Tool Actually Requires and What It Means for Your Platform

CE marking is not a one-time certification. Under MDR, manufacturers have ongoing post-market surveillance obligations that continue for the lifetime of the device monitoring clinical outcomes, reviewing flagged interactions, and demonstrating that the device continues to meet its clinical performance claims in real-world use. That commitment doesn’t end at certification. For platforms considering building their own medical reasoning capability, it’s where the real operational cost begins.

Onboarding Support

The Missing Layer in Your AI Agent: Why LLMs Need a Medical Reasoning Anchor

Your conversational AI agent can discuss symptoms fluently, ask follow-up questions naturally, and maintain context across long dialogues. But can it safely triage a patient experiencing chest pain? Large Language Models excel at conversation but lack the structured medical reasoning needed to make clinical decisions. Klinik AI provides the CE-marked reasoning layer that transforms conversational agents from healthcare chatbots into safe triage systems.

Book a Demo Today