Qiang Ma@ma_qiang244

18 months. 19 IVDR Notified Bodies. 74% reporting delayed technical documentation. This is the reality for medical device and IVD companies entering Europe. IVDR certification is not just a paperwork problem — it is a design problem. Teams often discover regulatory gaps only after the product has already been designed, tested, or submitted. Conformly is a Design-to-Certificate AI Agent that brings IVDR intelligence into product development from Day 1. It helps teams classify devices, map design decisions to regulatory requirements, detect evidence gaps, review risks and documentation, and prepare Notified Body-ready technical files. Instead of creating compliance documents after the fact, Conformly builds the evidence chain while the product is being designed. Our goal is simple: reduce late redesign, shorten documentation cycles, and help innovators move from product concept to IVDR readiness with more confidence.

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