Your FDA Pathway,
Managed End-to-End

We help Chinese medical device companies navigate the 510(k) process — from regulatory strategy to US market clearance — with professional project management expertise and our proprietary Control Tower platform.

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Pilot Software LLC dba 510k Bridge · Oregon, USA

Why Chinese Med-Device Companies Choose Us

🎯

Dual-Track Expertise

We manage regulatory and technology development in parallel — the same approach used by top US medical device firms — so you reach market faster.

🌏

US + China Bridge

Bilingual team with deep experience coordinating between Chinese R&D teams and US regulatory requirements. We also serve as your FDA-required US Agent — a mandatory point of contact for all foreign manufacturers selling into the US market.

📊

Control Tower Platform

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.

Services

SaaS Platform

Control Tower License

From $500/mo

  • Dedicated project dashboard
  • Bilingual setup wizard (EN/中文)
  • Dual-track milestone tracking
  • Regulatory document control
  • Real-time team messaging
  • Risk & budget monitoring
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Most Popular

Professional PM

$10–25K/mo

  • Everything in SaaS, plus:
  • Dedicated PMP project manager
  • FDA Communications Center (Q-Sub automation)
  • US Agent representation (FDA requirement)
  • Gate review management
  • Regulatory submission oversight
  • Supplier coordination
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Full Service

Enterprise

Project-based

  • Everything in Professional, plus:
  • Regulatory strategy & pathway
  • Automated RTA self-check & DHF readiness
  • US Agent representation (FDA requirement)
  • US entity formation assistance
  • End-to-end 510(k) management
  • Investor-ready documentation
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See the Control Tower in Action

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.

Dual-Track Dashboard

Dual-Track Dashboard

Technical and regulatory milestones tracked side by side — always know where both tracks stand.

Document Control

Document Control

ISO 13485-aligned lifecycle tracking with version history, review scheduling, and audit traceability.

Message Board

Message Board

Purpose-driven messaging — every thread tracks a decision, action, or status update tied to project execution.

All 15 Tabs — Complete Project Visibility

Dual-TrackDual-Track
Gate SystemGate System
RegulatoryRegulatory Tracker
RisksRisk Dashboard
AuditAudit Trail
DocumentsDocument Control
ActionsActions
TimelineTimeline
BudgetBudget
Cash/RunwayCash / Runway
US InvestmentUS Investment
ResourcesResources
SuppliersSuppliers
MessagesMessage Board
FDA CommsFDA Comms

What's New in Control Tower

Continuously evolving to simplify your FDA pathway.

🧙

Bilingual Setup Wizard

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.

🏛️

FDA Communications Center

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.

📋

RTA & DHF Readiness

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.

Free Resources

Download our guides and start your FDA journey today.

📘

FDA 510(k) Pathway Guide

Step-by-step guide for Chinese medical device companies entering the US market via the 510(k) pathway.

Download (English) 下载 (中文)
📋

Service Overview Fact Sheet

One-page overview of our platform, service tiers, and key capabilities for your 510(k) project.

Download (English) 下载 (中文)
🎓

PMP Certificate Course

Free project management certificate course — our gift to help you build the management discipline every FDA submission requires.

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Let's Talk

Schedule a free 30-minute consultation about your FDA pathway.

Email [email protected]
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Location

Oregon, USA
Serving clients in China and the United States