For medical sterilization equipment

An AI agent that watches your autoclaves
so you never miss a cycle.

Vigil monitors every sterilization cycle across every brand, auto-generates FDA 21 CFR Part 11 compliant documentation, and flags failures before they become inspections failures.

Live Cycle Monitor LIVE
Temperature
134.2°C
Pressure
2.1 bar
Phase
Exposure — 4:32 remaining
3,842 cycles monitored this month
100% documentation complete
0 compliance flags this quarter
24/7 autonomous monitoring

How Vigil works

One AI agent replacing manual log books, scattered spreadsheets, and the compliance scramble before every inspection.

Autonomous Cycle Monitoring

Works across Tuttnauer, Getinge, STERIS, Belimed, and every other brand. No hardware swaps, no vendor lock-in. Vigil reads the data your equipment already generates.

Auto-Generated Compliance Docs

Every cycle produces a 21 CFR Part 11 compliant record — electronic signature, timestamp, audit trail, no gaps. Ready for FDA inspection the moment you need it.

Failure Prediction

Tracks cycle count trends, temperature drift, and pressure variance to flag maintenance needs before a cycle fails. You fix it on your schedule — not in the middle of a surgical day.

Inspection-Ready Reports

One click generates your full compliance report — cycle history, biological indicator logs, maintenance records, all in the format regulators expect. Weeks of work in minutes.

Cycle Completion Report AUDIT READY
Cycle ID STL-2026-0617-4182
Timestamp 2026-06-17 08:42:31 UTC
Temperature 134.2°C — PASS
Pressure 2.1 bar — PASS
Dwell Time 4:32 — PASS
BI Result Negative — PASS
Electronically signed by: Ops Manager · 2026-06-17 08:42:44
21 CFR Part 11 · Record ID: 9F2A-K8X1-VIG-20260617

Paper logs fail inspections.
So does incomplete data.

FDA inspectors don't ask for your best effort. They want complete records — every cycle, every parameter, every signature. Vigil keeps every record, automatically, from every machine you connect.

No manual entry. No gaps. No scramble the night before an audit.

FDA 21 CFR Part 11 EU MDR Article 21 ISO 13485 ISO 17665 AAMI ST108

Sterile instruments. Complete records. Zero surprises.

Vigil runs in the background — watching every cycle, building every record, catching every issue before it becomes a problem.

Vigil never sleeps.