Submission prep takes weeks.
Your team manually pulls data from disconnected systems every time a 510(k), PMA, or De Novo deadline hits.
AI for medical compliance teams.
From FDA submission prep to adverse event reporting — we clean your data and automate the workflows that eat your team's week. Built for medical device, clinical research, and healthcare SaaS companies that can't afford AI to "kind of work."
The compliance work that shouldn't take this long.
Adverse event reports pile up.
Manual review of complaint data doesn't scale. Missed signals create regulatory exposure you can't afford.
Audit trails are a mess.
When the FDA asks, you can't show a clean chain of evidence in under a week. Sometimes not in under a month.
Three things that make AI actually work in medical compliance.
Data Foundation
We consolidate complaint data, submission documents, CAPA records, and quality data into a structured, queryable dataset. The boring work nobody wants to do — done properly so everything else works.
Workflow Automation
Automated adverse event triage, submission document assembly, complaint classification, and compliance reporting. Built around your QMS, not on top of generic tools.
Managed AI Operations
We maintain accuracy as FDA guidance updates and your product portfolio changes. New workflows added quarterly. No black boxes.
Three calls. No procurement theater.
Discovery call (30 min)
We learn your compliance workflow and identify where AI actually helps — and where it doesn't.
Scoping call (60 min)
We come back with a fixed-price proposal, clear deliverables, and a validation plan.
Build and handover
Working automation, full documentation, validation evidence. You own everything.
How we helped a Series A medical device company cut adverse event triage from 12 hours/week to under 2.
[Client] receives 200+ complaint reports per month across email, support tickets, and direct customer calls. Their two-person compliance team was spending 12+ hours each week manually classifying complaints, identifying reportable events, and assembling MDR submissions.
We built a structured complaint database from their fragmented sources, then deployed a classification model trained on their historical data. The team now reviews flagged events instead of triaging from scratch. Time to MDR submission dropped from 18 days to 4.
Questions medical compliance teams ask us.
Will this work with our QMS?
We integrate with Greenlight Guru, MasterControl, Veeva Vault, and most modern QMS platforms. If you're on something custom, we'll scope integration in the discovery call.
What about validation?
Every workflow we build includes a validation plan, IQ/OQ/PQ documentation, and test evidence. We've built systems that have passed FDA inspection.
Is our data safe?
We work within your infrastructure — AWS, Azure, GCP, or on-prem. Your data doesn't leave your environment. We sign BAAs.
What if FDA guidance changes?
That's exactly what the Managed Operations tier is for. We monitor guidance updates and adjust your workflows quarterly.
Do we need to be on a specific tech stack?
No. We work with what you have.
What we won't do.
We won't sell you AI you don't need. If your problem is a process problem, we'll tell you. If your data is too thin to train on, we'll tell you. We make money when we build things that work — not when we sell things that don't.
Find out if we can help.
A 30-minute call. No pitch deck. We'll tell you whether your problem is worth solving with AI — and whether we're the right team to solve it.