Solutions / Ship AI Through Compliance
Audit-Ready AI
You have an AI feature on the roadmap and a compliance team that has to clear it before anyone touches production. Most agentic dev shops sell speed. You can't trade speed for an audit finding. We ship in regulated markets — class II SaMDs with CE marking, government AI portals with encrypted audit trails, pharma applications under regulatory oversight — using a method we call Compliance by Design: GRC, legal, engineering, and product running alongside delivery, not after. Bring us the AI feature, the regulator, and the timeline.
Class II SaMD
CE-marked, shipped, running in regulatory production
60% faster
Average regulated launch when GRC runs alongside delivery, not after
What changes when compliance runs alongside delivery
Most regulated AI projects fail in the same shape: engineering ships a thing, legal and quality come in at the end, the audit reveals controls that should have been wired in from day one, and the launch slides a quarter. The agentic delivery shape we use is structurally different. Three things change as soon as GRC runs with the build, not after it.
Compliance by Design
GRC, legal, engineering, product, and quality run trans-disciplinary from day one. Audit trails, data residency, RBAC, and the controls regulators ask about are wired into the system, not bolted on for the next review. Ask us what that looks like for your specific framework.
Agentic delivery, controlled by design
Agentic workflows inside defined architectural boundaries are more controlled than ad-hoc human coding, not less. Every AI-generated output passes human review by engineers who understand the regulatory context. Auditors see logging, traceability, and the human-in-the-loop story they need.
Shipped in regulated markets, not just spoken about
Class II SaMDs with CE marking. Government AI portals with encrypted audit trails. Pharma applications under regulatory oversight. Compliance by Design isn't a methodology deck — it's how we've shipped real work in spaces where audit findings stop launches. Tell us your regulator.
Compliance by Design, not Compliance by Audit
Most agentic AI work today is built for speed: startups, prototypes, founders racing a window. Useful, but the buyer in a regulated market lives somewhere else. You ship into a context where an FDA letter, an EU AI Act audit, or a privacy-commissioner review can stop a product cold. Speed is necessary; audit-readiness is non-negotiable. The default approach — build first, audit later — assumes those two are sequential. They aren't. They're the same project, run differently.
We've been shipping in regulated markets for over a decade: medical devices with CE marking, government AI deployments, pharma apps under regulatory oversight. The receipts, the regulatory frameworks we have actual delivery experience against, and the method we'd run on your specific compliance posture are best handled in a conversation. If your AI feature is a quarter away from an audit you can't slip, that's the conversation worth starting.
Capabilities behind the work
Healthcare & Life Sciences
Software as a Medical Device
Build regulated healthcare software with delivery practices that can stand up to product and compliance pressure.
See how we help
Agentic AI
Agentic Solutions
Apply AI to product problems. Agents, workflows, and smart experiences that reset customer expectations.
See how we help
Agentic Product Engineering
Agentic Product Engineering
AI-augmented engineering workflows that ship production systems in weeks, not quarters.
See how we helpIf your compliance problem is shaped a little differently
Audit-ready AI sits next to a few adjacent problems we hear about in the same conversation. If your starting point is closer to one of these, begin there and we'll fold the compliance work in when it lines up.
AI feature work where the regulator isn't the primary constraint?
Ship AI features
Need to own the substrate underneath the audit, not just the AI feature on top?
Achieve sovereign architecture
Working off a legacy stack that can't carry an auditable AI feature without modernization first?
Modernize your stackAI feature on the roadmap. Audit on the calendar.
Tell us the regulator. We'll tell you the path.
Bring us the AI feature, the regulatory framework, and the timeline. We'll come back with an honest read on whether Compliance by Design fits your posture, what we've shipped in similar spaces, and what we'd push back on. No deck-ware, no compliance theater.
Talk to us