INTEGRITY GOVERNANCE FOR AUTONOMOUS SYSTEMS · SOFTWARE-ONLY · ZERO HARDWARE CHANGES
david@olikonste.com
Full technical briefing available under NDA
Next-Gen Surgical Robot Platform
EU Surgical Robot Deployment
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
PRIMARY REGULATION
DEPLOYABLE TODAY
6 DEPLOYABLE MODULES
▸ REGULATORY CONTEXT — WHY THIS MATTERS NOW
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REGULATORY DEADLINE
EU MDR + AI Act Arts. 9/12/13/14/15/17 (high-risk evidence obligations) — compliance evidence record required for every surgical session. EXOS-LINK supports this evidence workflow.

Your platform is designed for portability and broad surgical access — EXOS-LINK adds the runtime integrity layer that EU MDR and AI Act Arts. 9/12/13/14/15/17 require without modifying your existing sensing stack, producing a patient-session-linked evidence log on each integration run.
▸ LIVE DEMO — BUILT FOR YOUR PLATFORM
▶ Surgical Robot — Triple Regulation Demo
SCENARIO BUILT FOR SURGICAL ROBOT
Surgical integrity governor demo. Strictest safe-stop threshold active (surgical mode). EU MDR chain-of-custody logging active throughout. AI Act Art.14 human oversight condition logged with timestamp. Full recovery cycle demonstrated.
▶ LAUNCH DEMO — NO INSTALL REQUIRED
BODY MODEL INTEGRITY REGULATORY EVIDENCE GENERATOR SIGNAL INTEGRITY LAYER TRUST-STATE GOVERNOR DISTRIBUTED TIMING INTEGRITY NOISE SUPPRESSION
▸ REGULATORY COVERAGE — WHAT THIS ADDRESSES
EU MDR
SUPPORTS EVIDENCE
Supports evidence and record-keeping obligations for EU MDR. Final conformity assessment depends on system classification, intended use, and integrator. Tamper-evident audit log generated on each integration run.
AI Act Arts. 9/12/13/14/15/17
SUPPORTS EVIDENCE
Supports evidence for Arts. 9, 12, 13, 14, 15, and 17 (high-risk provider obligations). Tamper-evident audit log generated on each integration run.
Machinery Reg Jan 2027
SUPPORTS EVIDENCE
Supports evidence and record-keeping obligations for Machinery Reg Jan 2027. Final conformity assessment depends on system classification, intended use, and integrator. 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.
Dual MDR + AI Act evidence pathway.
✉ REQUEST 20-MIN CALL
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.