We help Chinese medical device companies navigate the 510(k) process — from regulatory strategy to US market clearance — with Stanford-trained project management and our proprietary Control Tower platform.
Pilot Software LLC dba Arch Medical Management · Oregon, USA
We manage regulatory and technology development in parallel — the same approach used by top US medical device firms — so you reach market faster.
Bilingual team with deep experience coordinating between Chinese R&D teams and US regulatory requirements. We speak your language — literally.
Our proprietary project management dashboard gives you real-time visibility into every milestone, risk, document, and budget item — with a guided setup wizard and built-in FDA automation.
From $500/mo
$10–25K/mo
Project-based
Our 15-tab dashboard manages every aspect of your FDA journey — from a guided setup wizard through dual-track development, FDA communications automation, and team collaboration.
This is a live demo — explore the tabs to see how we manage medical device projects.
Continuously evolving to simplify your FDA pathway.
A guided 9-step wizard pre-populates your entire project dashboard — team roster, budget, milestones, suppliers, and risk register — in English or 中文. Start managing in minutes, not days.
Auto-generate Q-Sub cover letters, export structured question packages, run a 14-item RTA self-check cross-referenced with your DHF, and track FDA interaction milestones — all from one tab.
Real-time readiness scoring pulls from your Design History File and Standards trackers. Know exactly where you stand before submitting — and avoid the 30% RTA rejection rate.
Download our guides and start your FDA journey today.
Step-by-step guide for Chinese medical device companies entering the US market via the 510(k) pathway.
Download (English) 下载 (中文)Free project management course from Stanford — our gift to help you build the management discipline every FDA submission requires.
Request AccessSchedule a free 30-minute consultation about your FDA pathway.
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Oregon, USA
Serving clients in China and the United States