AI-enabled process revolution for engineering teams
Revolutionize Development.
Ship Faster With Leaner Teams.
Zenchini revolutionizes standard change-control and development workflows for medical devices and AI-enabled software— mapping design intent to risk, verification, and regulatory evidence before release. Outcome: faster delivery, leaner teams, and higher morale.
Note: Zenchini provides operational guidance and document scaffolds. It does not provide legal advice or guarantee regulatory outcomes.
How It Works
1) Delta-First Intake
Tell Zenchini what you’re trying to achieve and what changed. Drop the files you already have (drawings, requirements, test history, BOM, risk file, release notes).
2) Predictive Impact Mapping
Zenchini identifies phase and impact across functions (EE/ME/FW/SW/Test/Quality/Reg/Supply Chain), then maps design intent to risk, verification, and evidence needs.
3) Build-Ready Execution Packet
You get a change-control packet (or NPD plan): updated docs + risk delta + verification plan + lab/sample needs + a week-by-week schedule.
Use Cases
Engineering Change (ECO/ECN)
Example: need larger simulation output waveform → circuit change. Zenchini generates the impacted drawing updates, risk delta, verification plan, and schedule.
End-of-Life (EOL)
Discontinuation planning and closure evidence: field impact review, complaints trend check, servicing/spares plan, labeling updates, and closure checklist.
New Product Kickoff
Start from any phase. Zenchini establishes the minimum spine for requirements, risk, verification, and evidence to move toward a releasable build.
What You Get (Example Outputs)
Change-Control Ticket
- Scope + release goal
- Owners + decision log
- Gates + “human review required” items
Risk + Verification Mapping
- Risk delta (new/changed failure modes)
- Verification plan (bench + regression + system)
- Retest triggers + evidence map
Document Pack
- Updated drawings + revision notes
- Engineering rationale
- Protocols + test records templates
Workback Schedule
- Sample/build quantities
- Fixture + lab needs
- Week-by-week plan to next releasable build
About
Zenchini comes from “Zen”—clarity, calm, and focus. Our goal is simple: disciplined execution that feels calm, not chaotic.
Get Started
For friends-only beta, use the private chat to start a case.
Tip: start with “what changed” and your target release date.
Feedback
Have thoughts, ideas, or a use case you want to try? Email us and we’ll incorporate it into the beta.