INTEGRITY GOVERNANCE FOR AUTONOMOUS SYSTEMS · SOFTWARE-ONLY · ZERO HARDWARE CHANGES
david@olikonste.com
Full technical briefing available under NDA
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 CLASS IIA+
PRIMARY REGULATION
DEPLOYABLE TODAY
6 DEPLOYABLE MODULES
▸ REGULATORY CONTEXT — WHY THIS MATTERS NOW
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REGULATORY DEADLINE
Triple exposure: EU MDR and the 2028 delegated act (high-risk evidence obligations) + Machinery Reg. One integration supports the tamper-evident audit log all three frameworks require.

Your surgical platforms already set the standard for surgical precision — EXOS-LINK adds the tamper-evident audit layer that EU MDR and the 2028 delegated act require, with a patient-session-linked evidence log suitable for post-incident technical review.
▸ LIVE DEMO — BUILT FOR YOUR PLATFORM
▶ Surgical Robot — Triple Regulation Demo
SCENARIO BUILT FOR SURGICAL ROBOT
8-node surgical arm model. Enhanced safety threshold — surgical mode. Triple regulation signed compliance evidence live: EU MDR chain-of-custody and the 2028 delegated act + Machinery Reg. Clinical event log with patient session ID.
▶ 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 Class IIa+
SUPPORTS EVIDENCE
Supports evidence and record-keeping obligations for EU MDR Class IIa+. Final conformity assessment depends on system classification, intended use, and integrator. Tamper-evident audit log generated on each integration run.
AI Act — via 2028 delegated act
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 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 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.