Device engineering · regulatory · quality
Medical device programs, 10x’d.
Design, documentation, verification and regulatory work for device teams. AI does the drafting; named engineers review, correct and sign. You get a fixed price against a written scope before anything starts.
Live · openFDA 510(k)
How long does FDA take to clear a device like yours?
Try
Public FDA clearance data, straight from the source. Nothing you type is stored.
- Clearances since
- Median FDA review
- Most recent decision
- Fixed price Quoted against a written scope. Scope surprises surface at quote time, not in an invoice.
- Named reviewer Every AI-assisted deliverable ships with a review record: who reviewed what, and what they corrected.
- Your data stays yours Your documents are never used to train any model. How we handle them.
Services
Across the device lifecycle
- Start here · Document & Remediate Remediate 10x A scored DHF gap report in 72 hours. Lead time · 72 hours
- Document & Remediate Develop 10x A submission-ready Class II DHF in 6 weeks. Lead time · 6 weeks
- Verify & Test V&V 10x Verification testing without the bottleneck. Lead time · 1 week
- Design & Prototype Design 10x Concept to machined prototype and design review record. Lead time · 4–6 weeks
- Design & Prototype Surgeon Idea → First Build Clinical insight to working prototype and IP scan. Lead time · Quoted per concept
- Migrate CADBridge CAD migration without the re-drawing tax. Lead time · 2–3 weeks
- Intelligence Pulse Know what AI tells surgeons about your device. Lead time · 1 week
- Launch Demo Video 10x A narrated demo video of your device, built from your CAD. Lead time · Script first
How an engagement runs
Three steps, no surprises
- 01
Scoping review
Tell us what you are trying to clear and what is in the way. We say plainly whether we are the right fit — and when we are not.
- 02
Fixed-price quote
A written scope and one price. We take a small number of concurrent programs, so the engineers named on the quote do the work.
- 03
Reviewed delivery
AI drafts and accelerates; people decide and sign. Each deliverable arrives with its review record attached.
Evolve your company. Keep your judgment.
AI tools and services for medical device teams. The tools draft, a named person signs, and the review record ships with the work — nothing leaves without a human's sign-off on it.
Concept film, 1:26, with sound. Every interface in it runs on synthetic data against a fictional device, and says so on screen — the words are in the picture as well as in the audio.
Free tools
Try the work before you buy it
Built on public FDA data and published standards. No account, no charge, and they run in your browser.
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DHF Self-Check
Score your Design History File against 21 CFR 820.30 and ISO 13485 design controls. "Not sure" scores as auditor exposure.
Goes deeper in Remediate 10x
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Pre-Sub Question Tester
Test draft Q-Submission questions against FDA guidance before the meeting request goes in.
Goes deeper in Develop 10x
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PredicateScope
Every 510(k) under a product code, with the review times computed from the public record.
Goes deeper in Develop 10x
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Device Designer
Step-by-step medical device development roadmap: unmet clinical need, FDA classification, timeline, costs, V&V, Notified Bodies, and commercial launch.
Goes deeper in Design 10x
Start a conversation
Tell us what you are working on
What are you trying to clear, and what is in the way? These reach a person, not a queue, and a person replies to them.