EU regulatory deadlines create binding evidence obligations for this platform category. EXOS-LINK adds runtime integrity monitoring and tamper-evident compliance evidence — zero hardware changes required.
ON REQUEST
COMMERCIAL TERMS
EU MDR PATHWAY
PRIMARY REGULATION
DEPLOYABLE TODAY
6 DEPLOYABLE MODULES
▸ REGULATORY CONTEXT — WHY THIS MATTERS NOW
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REGULATORY DEADLINE
EU MDR + Machinery Reg Annex III. Your powered exoskeleton and orthotics platform in EU clinical use needs documented sensor integrity records per session.
Your platform already leads on safety —
▸ LIVE DEMO — BUILT FOR YOUR PLATFORM
▶ Exoskeleton — Gait Assistance Integrity Demo
SCENARIO BUILT FOR PROSTHETICS & EXOSKELETON
Per-joint health monitoring across all lower limb joints. Progressive fault scenario with tamper-evident audit log. Compliance evidence mapped to EU MDR and Machinery Regulation Annex III simultaneously.
BODY MODEL INTEGRITY · PROSTHETICSREGULATORY EVIDENCE GENERATORSIGNAL INTEGRITY LAYERTRUST-STATE GOVERNORDISTRIBUTED TIMING INTEGRITYNOISE SUPPRESSION
▸ REGULATORY COVERAGE — WHAT THIS ADDRESSES
EU MDR pathway
SUPPORTS EVIDENCE
Supports evidence and record-keeping obligations for EU MDR pathway. Final conformity assessment depends on system classification, intended use, and integrator. Tamper-evident audit log generated on each integration run.
Machinery Reg Annex III
SUPPORTS EVIDENCE
Supports evidence and record-keeping obligations for Machinery Reg Annex III. Final conformity assessment depends on system classification, intended use, and integrator. Tamper-evident audit log generated on each integration run.
MR Annex III §1.1.9
SUPPORTS EVIDENCE
Supports evidence outputs for MR Annex III §1.1.9. Tamper-evident audit log generated on each integration run.
Ready to discuss a pilot?
Pilot scope and timeline available on request.
REST / ROS2 / file tail — same schema. Output: signed compliance evidence on each integration run.
Medical exoskeleton compliance pathway.
All company names, product names, and trademarks referenced on this page are the property of their respective owners. Olikonste Systems AB is not affiliated with, endorsed by, or in partnership with any of the companies named. This page is an independent technical overview prepared for informational purposes only. Nothing on this page constitutes legal advice or a conformity assessment. Final regulatory classification, conformity assessment, and compliance determination depend on system classification, intended use, and the responsible integrator or manufacturer.