Surgical robotics, cleared with the regulator.
Tomco ran IEC 62304, ISO 14971, and FDA SaMD evidence for a robotic surgery platform — with an AI-assist module under ISO/PAS 8800 and the EU AI Act high-risk regime.
How the engagement ran.
The client's next-generation robotic surgery platform combines a teleoperated arm with an AI-assist module that suggests instrument trajectories. The combined system is a Class III FDA medical device, regulated under IEC 62304 (software lifecycle), ISO 14971 (risk management), and the EU MDR — with the AI-assist additionally subject to ISO/PAS 8800 and the EU AI Act high-risk regime.
Tomco ran the full IEC 62304 Class C software safety case, the ISO 14971 risk file, and the FDA SaMD evidence package. AFSPs co-signed every release; agents kept the traceability matrix from user need → requirement → design → test → release current to the minute across a multi-vendor codebase.
FDA pre-submission review came back clean on the first cycle — zero findings — and the AI-assist module was the first surgical-AI feature in its class to land a defensible ISO/PAS 8800 argument paired with EU AI Act conformity evidence.
Who signed it.
Names withheld by policy. Credentials and program references verifiable on request under NDA.
The regime, line by line.
One signed thread, end to end.
- 01User needs & clinical context — formalised hazard inputs
- 02Software architecture — IEC 62304 Class C decomposition
- 03Risk management — ISO 14971 file, full hazard-to-control trace
- 04AI-assist module — ISO/PAS 8800 lifecycle + EU AI Act technical file
- 05V&V — unit, integration, system, clinical simulation
- 06Signed release — AFSP co-signature, FDA pre-sub package, CE technical file
Want this for your program?
We embed AFSPs and agents into your safety case the same way we did on this engagement. Client references available under mutual NDA.