Da Vinci systems in EU operating theatres face triple regulatory exposure: EU MDR Class IIa+ for medical device classification, EU AI Act Art.22 for high-risk medical AI, and Machinery Regulation from January 2027. Every surgical session needs a chain-of-custody integrity log.
ON REQUEST
COMMERCIAL TERMS
EU MDR CLASS IIA+
PRIMARY REGULATION
DEPLOYABLE TODAY
6 COMMERCIAL PATENTS
▸ YOUR COMPLIANCE GAP — WHY THIS MATTERS NOW
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IDENTIFIED COMPLIANCE EXPOSURE
Triple exposure: EU MDR + AI Act Art.22 (medical AI) + Machinery Reg. One integration produces the chain-of-custody evidence log all three require.
Your da Vinci systems already set the standard for surgical precision — EXOS-LINK adds the chain-of-custody runtime integrity layer that EU MDR and AI Act Art.22 require, with a patient-session-linked evidence log that is independently verifiable post-incident.
▸ LIVE DEMO — BUILT FOR YOUR PLATFORM
▶ Surgical Robot — Triple Regulation Demo
RECOMMENDED FOR INTUITIVE SURGICAL
8-node surgical arm model. Enhanced safety threshold — surgical mode. Triple regulation compliance live: EU MDR chain-of-custody + AI Act Art.22 + Machinery Reg. Clinical event log with patient session ID.
Pilot scope and timeline available on request.
REST / ROS2 / file tail — same schema. Output: trust_state + signed evidence pack on every run.
Dual compliance pathway.