We Build AI Agents for the People
Doing the Hard Work
In medical devices & regulated manufacturing — and across healthcare & life sciences, payers, pharma, and other regulated industries — we turn your most manual, compliance-heavy work into enterprise-grade AI agents, so your team can focus on the work only they can do. Deployed in weeks, built to your standards.
We’ll Build Your First Agent and Train Your Team on Anything AI, Free
We’re a new firm with twenty years of regulated-enterprise experience behind it, and we’re selecting a small group of founding clients to prove it. Founding clients get a hands-on taste of both things we do (a custom agent and a custom training on anything AI) at no cost.
The AI Agent
A working agent on one real process
Pick one high-impact, compliance-heavy process. We build a working agent around it, inside your guardrails.
- Discovery & requirements documentation
- POC development and demo
- A working agent
The AI Training
A custom training on whatever you need
Not about the agent we build. It’s a session we’ll put together around your team’s actual AI learning needs.
- Discovery & requirements documentation
- POC development and demo
- A custom-built training module, not an off-the-shelf course
Start with one or take both. Your call. One real process is all we need to begin.
What we ask in return
- One real process and the access to build against it
- Your candid feedback as we build
- Your openness to letting us mention we work together
That’s the whole exchange. No fee, no long contract — anything more is entirely up to you and your company’s policies.
4 of 5 slots remaining · open through Q3 2026
Where Could Your Quality Team Get Hours Back —
Especially Before an Audit?
A focused, 5-minute self-assessment for senior quality and regulatory leaders. Built around the operational realities of FDA-regulated manufacturing: your records, your processes, your team. At the end you'll see your readiness tier and a short summary; we'll send the full interpretation and recommended next step to your email.
No technical AI knowledge required · The questions are about your operation, not the technology
Also available from our Resources section · 5 minutes · No obligation
The work that's too important to rush — and too manual to scale
In regulated industries, your best people spend their days on work that's repetitive, documentation-heavy, and unforgiving of error: intake and triage, case and claims review, regulatory documentation, quality and compliance checks, vendor and data diligence.
You can't just throw generic automation at it. One wrong output carries real regulatory and patient risk. So it stays manual. It stays slow. And it stays expensive.
We build AI agents that take on that work inside your compliance guardrails, so your experts spend their time on judgment, not on keystrokes.
Agents built around your real processes — not generic templates
We don't sell off-the-shelf bots. We map your actual workflows, pain points, and compliance requirements, then build agents that fit them.
Clinical & Patient Operations
Agents that handle intake, triage support, prior-authorization prep, and documentation, freeing clinical staff for care.
Regulatory & Quality
Agents that draft, check, and route regulatory documentation and quality records under your QSR and compliance standards.
Claims, Cases & Reviews
Agents that accelerate case review, claims processing, and exception handling with full audit trails.
Vendor, Data & Diligence
Agents that assess vendors, data-retention policies, and compliance posture: work you currently do by hand.
Don't see your process here? That's the point. We build to yours. → Book a Discovery Call
High-impact agents for FDA-regulated manufacturing
We come from FDA-regulated, electronics and medical-device contract manufacturing, so we see agent opportunities most AI shops miss.
CAPA & Nonconformance Agent
Drafts and routes corrective/preventive action and nonconformance records, keeping audit trails intact.
Supplier Qualification & Audit-Prep Agent
Assembles supplier documentation, flags gaps, and prepares you for FDA and ISO audits.
Quality-Record Review Agent
Checks device history and batch records for completeness before release.
RFQ & Quote-Response Agent
Accelerates RFQ intake and quote preparation, speeding the work that drives revenue in thin-margin manufacturing.
Working agents, not slideware
These are agent patterns we build and deploy: practical, production-shaped, and integrated with the tools you already run.
Website Sales Assistant
Answers visitor questions in real time, captures and qualifies leads straight into Salesforce, and books meetings on your team's calendar.
Regulatory & Quality Agents
Draft, check, and route compliance documentation under your standards, with full audit trails and human-in-the-loop review.
Process-Specific Custom Agents
Built to your exact workflow after a short discovery, fitted to your stack, your data, and your compliance posture.
Built for regulated industries — proven where the stakes are highest
Our roots are in the most demanding compliance environments there are. We bring that discipline to every engagement.
Medical Devices & Regulated Manufacturing
Deep experience inside FDA Quality System Regulation (21 CFR 820) environments and electronics/medical-device contract manufacturing. We speak QSR fluently. Most AI shops don't.
Explore Medical Devices & Regulated ManufacturingHealthcare & Life Sciences
Provider operations, payer workflows, and life-sciences commercial and regulatory teams, where one wrong output carries real patient and regulatory risk.
Explore Healthcare & Life SciencesA proven path from idea to deployed agent
A systematic approach that turns your operations into working AI agents in record time, delivering value fast while protecting you at every step.
Discovery & Analysis
Deep dive into your current processes, pain points, and future-state objectives to identify the highest-impact agent opportunities.
- High Impact Use Cases
- Requirements for Use Case(s)
- ROI Assessment
POC Development
Build a lightweight Proof of Concept to validate the proposed agent, demonstrate value, and assess feasibility before full development.
- Functional Prototype
- Feasibility Report
- Stakeholder Demo
Development & Integration
Build and configure intelligent agents using leading AI models, integrated seamlessly with your existing workflows.
- Custom AI Agents
- Integration
- Testing & Validation
Deployment & Continuous Optimization
Launch your agent into production with full training and monitoring, then continuously tune and refine it against real-world performance, so it keeps doing the right things as your processes evolve.
- Production Go-Live
- Team Training
- Performance Monitoring
- Agent Tuning & Refinement
Why teams trust us with their hardest work
Prototyping an agent is easy. Getting one safely into production inside a regulated enterprise is the hard part — and it's what we've done for 20 years.
We build agents that actually ship.
Plenty of tools can demo an agent. We build them to survive the compliance, integration, and change-management gauntlet of a real regulated enterprise, because that's our background.
Compliance is in our DNA.
We come from FDA-regulated, audit-heavy environments and build agents that respect your data-retention, monitoring, and audit requirements from day one.
Platform-flexible by design.
We build on the AI stack that best fits your environment, compliance requirements, and whatever you've standardized on, from Salesforce Agentforce to Microsoft Copilot to leading foundation models. The value is the regulated-industry discipline we wrap around it, not any one vendor.
Start with a 2-Week Agent Pilot
Once founding slots are filled, here's how everyone else starts. In two weeks, for a fixed fee, we'll take one real process and build a working agent proof-of-concept around it, with feasibility, ROI, and compliance assessment included. If you move forward, the pilot fee credits toward your full build.
What's included
- Fixed fee, fixed timeline, no open-ended risk
- A working POC on your real process
- Feasibility, ROI, and compliance assessment included
- Fee credited toward a full engagement
Be One of Our First — and Get an Agent Built Free
Tell us the one manual process slowing your team down. If it's a fit, it becomes your founding build. 4 of 5 slots remaining.