If you make devices in a small shop, you carry the same record-keeping burden as a company fifty times your size — with none of the staff. Sentinel builds the system that carries it for you.
Nearly every finding in a small device shop traces back to a record that existed but couldn't be produced, or a loop that was opened and never closed. Those are system problems, not effort problems.
DHR · DMRDevice history and device master records tied to the part, the lot, and the people who signed off — not scattered across binders and a shared drive.
CAPAEvery CAPA carries an owner, a due date, a root cause, and verified effectiveness. Overdue items surface on the dashboard instead of surfacing during an audit.
COMPLAINTSLog the complaint, record the investigation and the reportability decision, and link it to whatever nonconformance or CAPA it produced.
TRAININGWho is qualified to run which process, when they were trained, and when that qualification expires — the clause 6.2 evidence, kept current.
SUPPLIERSApproved supplier status, incoming defect history, and supplier corrective action requests kept against the supplier file.
READINESSA running readiness view that shows which areas have gaps months before a surveillance audit, rather than the week before.
The enterprise eQMS platforms aimed at device manufacturers are genuinely capable — and genuinely priced for companies with a full-time quality department and an IT budget. Per-seat licensing punishes you for putting the system in front of operators, which is exactly where the records get created.
The other direction — a template or a stack of spreadsheets — fails differently. It works until three people touch the same file, or someone moves a column, or the one person who understood the workbook leaves.
A Sentinel build sits between those. We map how your shop already documents things, build a system around that reality, and hand it to you. You own it outright. There is no per-seat cost, so every operator and inspector can use it, and no monthly fee at all unless you want us to keep managing it.
Sentinel is a record-keeping and tracking system. It helps you organize the evidence an auditor looks for; it does not replace the judgment of your quality team, and using it does not by itself guarantee ISO 13485 certification, FDA clearance, or any other regulatory outcome.
Walk through a working system with sample records — nonconformances, CAPAs, supplier actions, and readiness — then tell us what your shop actually needs.
See the Live Demo