FDA-VALIDATION ADVISORY
Validation paperwork is the bottleneck between your AI feature and your FDA submission. We use AI agents to compress the paperwork without compromising the rigor.
PROBLEM 1
Design controls, V&V, traceability matrices, risk files. Every release. Manual. Expensive. Slow. The team that ships the product is the team that documents it, and they do not scale.
PROBLEM 2
FDA's AI/ML guidance (Predetermined Change Control Plan, Good Machine Learning Practice, SaMD framework) is evolving. Off-the-shelf consultants do not yet know how to translate it into shipping code.
PROBLEM 3
Agents draft what your team would have drafted anyway. Your team reviews and signs. That is how AI gets into a regulated workflow safely, with accountability intact.
Three tiers. Fixed-price engagements with named deliverables. Discovery call is free.
TIER 1
2-4 weeks · fixed price
A senior outside read on your current AI/DSP/ML architecture in the context of FDA requirements, plus a 12-month prioritized roadmap.
TIER 2 · POST-REVIEW
8-16 weeks · fixed price
Fixed-scope, fixed-price build of priority items from your Architecture Review roadmap. We ship working software with the regulatory deliverable set.
TIER 3
rolling · 3-month minimum
Monthly engagement for clients who finished an Implementation and want ongoing access to the architect and the regulatory pipeline.
OUR APPROACH
AgentMedReg is our proprietary multi-agent architecture for FDA-regulated software development. Ten agents covering regulatory strategy, risk management, design controls, V&V, human factors, and CAPA, with a bookend pattern that opens and closes every engagement.
We invented it because we needed it. It runs on our own engagements before it runs on yours.
Read: When AI meets FDA →10 AGENTS · BOOKEND PATTERN
RIGHT FIT
NOT A FIT
FOUNDER BACKGROUND
Abel Villca, founder and architect. Background includes Roche and Silicon Valley health-tech startups. Has sat through pre-sub meetings, written design control documents, and shipped AI features under 21 CFR 820.
More about Abel and the team →SENIOR ADVISOR REVIEW
Every engagement is reviewed by a matched senior advisor. PhD in distributed systems (University of Geneva), PhD in laser physics and DSP (Belarusian State University), Swiss embedded-systems industry experience. Senior advisor signs off on the architecture report's domain-specific section.
Meet the senior advisors →01
30 min call, free. Mutual NDA available. Decide if it's a fit.
02
$15,000 · 2-4 weeks. Deliverable: gap analysis + roadmap.
03
If you continue: fixed-price build against the roadmap. 8-16 weeks.
04
Ongoing monthly engagement to keep design controls current.
No. We complement them. They handle submission strategy and FDA interactions; we handle the software, AI, and the agent-augmented documentation that connects the two.
Agents we deliver to your product are validated as part of your QMS just like any other software. Our internal tooling agents (used to draft your paperwork) are tools your team reviews. They do not sign off, your team does.
Part 11 considerations are part of every engagement. We help you map workflows to Part 11 requirements; we do not sell Part 11 software as a product.
We actively track FDA's AI/ML lifecycle program, GMLP, PCCP guidance, and SaMD framework. Public references on our blog.
Yes, mutual NDAs as standard. Template available on request.
Yes. Our deliverables are designed to slot into your QMS, not replace it.
Seattle (architecture, sales, client-facing) plus a UPB Computer Science engineering bench in Cochabamba, full US business-day overlap. Senior advisors based in Switzerland and Europe. All client-facing work is in English.
30-minute discovery call. Free. Mutual NDA available. We use it to decide whether we are a fit before anyone signs anything.
Book a discovery call