Your FDA Pathway,
Managed End-to-End

We help Chinese medical device companies navigate the 510(k) process — from Pre-Submission strategy through MDUFA review 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, MDUFA tracking)
  • 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 17-item RTA self-check, SE decision flow & 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 17-item RTA self-check (21 CFR 807) cross-referenced with your DHF, walk through the 5-point SE decision flowchart, track Pre-Sub and MDUFA review timelines, and navigate disagreement escalation — all from one tab.

📋

RTA & DHF Readiness

Real-time readiness scoring pulls from your Design History File and Standards trackers — covering eCopy, user fees, FDA Form 3881, device description, SE discussion, proposed labeling (21 CFR 801), and consensus standards (FDA Form 3654). Know exactly where you stand before FDA's Day 15 RTA screening — and avoid the 30% 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 info@510kbridge.com
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Location

Oregon, USA
Serving clients in China and the United States