A quality system for medical device startups, with an AI quality engineer inside it.
The AI drafts the records, lines up the approvals, and finds what is missing; a person signs. Built so a small team gets through its first audit without hiring for the paperwork.
The AI does the paperwork.
An AI quality engineer that has read every document in your system and the standards you are audited against. It takes an engineer's change and drafts it into the SOP and the forms it touches, and lines up the approvals.
Approvals requested · M. Alvarez, S. Chen
A person signs. Every action is a record.
The AI cannot approve anything, and it cannot make a document effective. A person reviews its work and signs it into document control under their own name, and every draft and finding the AI makes is its own attributed entry in the audit trail, next to the person who accepted or rejected it.
- AIDrafted Rev C from CO-31
- AIFlagged a stale reference in FRM-112
- MAReturned the draft with a note
- MASigned Rev C into document control
It finds the gaps before the auditor does.
The AI keeps watch as your system changes and raises what it finds without being asked: the procedure ISO 13485 expects that nobody has written, the review an SOP promises that the records never show, the reference pointing at a revision that moved on. Underneath, the layout is the one ISO 13485 and the FDA's QMSR ask for: document control, change control, signatures with the Part 11 controls a system can carry, an audit trail under everything.
- GapNo procedure for supplier evaluation7.4.1 asks for one
- GapSOP-11 promises an annual review; the records stop in 2025
- StaleWI-31 cites SOP-4 Rev B; current is Rev D
Each finding drafts its own change order.
- Who
- Two engineers in San Jose. One of us led engineering at a device startup from first grant to ISO 13485 certification; the other spent seven years at Google on Fuchsia's networking stack. More about the two of us
- Status
- No product to sell yet; building document control, signatures and the audit trail first. Five device-team conversations so far. Incorporated August 2026.
Talk to us
Tell us how quality runs where you are.
Leave your email and we will write back with which documents your first audit needs and which can wait.