Ottobock's Exo-H3 and powered orthotic systems in EU clinical and industrial settings face EU MDR classification and Machinery Regulation Annex III from January 2027. Every session needs documented sensor integrity evidence for both regulatory pathways.
ON REQUEST
COMMERCIAL TERMS
EU MDR PATHWAY
PRIMARY REGULATION
DEPLOYABLE TODAY
6 COMMERCIAL PATENTS
▸ YOUR COMPLIANCE GAP — WHY THIS MATTERS NOW
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IDENTIFIED COMPLIANCE EXPOSURE
EU MDR + Machinery Reg Annex III. Exo-H3 and powered orthotics in EU clinical use need documented sensor integrity records per session.
Your Exo-H3 and powered orthotics are already in EU clinical use — EXOS-LINK adds the runtime evidence layer that EU MDR and Annex III require, producing a hash-chained log on every session with zero modification to your existing hardware.
▸ LIVE DEMO — BUILT FOR YOUR PLATFORM
▶ Exoskeleton — Gait Assistance Integrity Demo
RECOMMENDED FOR OTTOBOCK
Per-joint health monitoring across all lower limb joints. Progressive fault scenario with hash-chained evidence log. Compliance evidence mapped to EU MDR and Machinery Regulation Annex III simultaneously.
Pilot scope and timeline available on request.
REST / ROS2 / file tail — same schema. Output: trust_state + signed evidence pack on every run.
Medical exoskeleton compliance pathway.