AI FOR FDA-REGULATED SOFTWARE · PRODUCTIZED AGENTS · MULTI-AGENT IN PRODUCTION

AI for FDA-regulated software.
And the agents that ship faster.

We help medical device and digital health companies ship AI features with FDA-grade rigor. We also build productized AI agents for ops and engineering teams who need an automation in weeks, not months.

Engineers from Roche and Silicon Valley health-tech. PhD advisors from Europe and Swiss industry. Multi-agent systems in production daily.

FOR MEDTECH AND DIGITAL HEALTH TEAMS

FDA-Validation Advisory

Ship AI features with FDA rigor. Use agents to compress the validation paperwork that slows your team down.

  • · AI/ML feature validation under FDA guidance
  • · AgentMedReg-augmented design controls and V&V
  • · Risk file and traceability under IEC 62304 / ISO 14971 / 21 CFR 820

Starting at

$15,000

Architecture Review

Explore →
FOR OPS AND ENGINEERING LEADERS

AI Agent Studio

Get a production-grade AI agent in 2-4 weeks. Fixed price. No surprise bills. 6 productized shapes to start.

  • · Build Sprint: $3,500 / $7,500 / $15,000 by scope
  • · Agent Operations: $499 to $2,499 per month, fully managed
  • · Bring your own LLM keys, or use ours

Starting at

$3,500

Compact Build Sprint, 2 weeks

See shapes and pricing →

Why us

Three things make Nananami credible in a market crowded with generalists.

PRODUCTION DEPTH

Multi-agent systems in production daily

AgentForge, AgentMedReg, AgentMinds are not tutorials. They run on our own engagements before they run on yours. Most consultants are still writing blog posts about the patterns we've already shipped.

FDA, BY ENGINEERS

FDA experience with software, not just paper

Built by engineers who have worked at Roche and Silicon Valley health-tech startups. We have sat through pre-sub meetings, written design control documents, and shipped AI features under 21 CFR 820.

FAIR PRICING DISCIPLINE

Fixed price, no quiet scope cuts

Our engineering bench is UPB Computer Science-trained, English-fluent, with full US business-day overlap. That structure lets us hold a fixed price without downgrading scope. The savings show in your invoice, not in our margins.

How we work

01

Discovery

30 min call, free. We decide if it's a fit before anyone signs.

02

Scope & quote

Written SOW with fixed price, fixed timeline, and named deliverables.

03

Build / engage

Weekly progress. You see the design before code starts.

04

Handoff

Working software, runbook, recorded walkthrough, 30-day bug-fix window.

CASE STUDY · SILICON VALLEY HEALTH STARTUP

How we built an AI-augmented signal processing pipeline for a Class II diagnostic device, ready for design controls.

Read the full case study (coming soon) →

Monthly notes on AI + FDA + multi-agent systems.

From our own engagements, not from secondhand sources.

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FDA-VALIDATION ADVISORY

Get an FDA Architecture Review

$15,000 · 2-4 weeks · 25-40 page report

AGENT STUDIO

Start with a Build Sprint

From $3,500 · 2-4 weeks · fixed price