Your FDA Pathway,
Managed End-to-End

We help 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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Why 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.

📊

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.

💰

Investor Relations

We help you fundraise at the right time. Our 510(k) Bridge strategy maps investor outreach to regulatory milestones — connecting you with US investors when FDA progress gives you maximum leverage for term sheets and valuation.

How It Works

Three steps from first call to FDA clearance

1

Schedule a Call

Free 30-minute consultation to assess your device, predicate strategy, and timeline.

→
2

Launch Control Tower

We set up your tri-lingual dashboard, map milestones, and kick off the dual-track plan.

→
3

Submit & Clear 510(k)

We manage every gate, document, and FDA interaction through to clearance.

Services

SaaS Platform

Control Tower License

From $500/mo

Three tiers — all include tri-lingual setup (EN/中文/한국어):

  • Starter — $500/mo: 1 project, dedicated dashboard with dual-track milestone tracking, real-time messaging & gate reviews, risk & budget monitoring
  • Growth — $1,000/mo: 2 projects, everything in Starter plus full regulatory document control, audit trail, and ISO 13485 document lifecycle management
  • Scale — $2,000/mo: Unlimited projects, everything in Growth plus FDA Communications Center, Q-Sub builder, RTA self-check, PMP-led project orchestration, and a guided ClearPulse tutorial for onboarding your team

A typical 510(k) program costs $150K–$400K. Our dashboard at $500–2,000/mo over 18 months is $9K–$36K — just 5–10% of total program cost for full project visibility.

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Quality System

QMS-Lite for Startups

$200–500/mo

A lightweight quality management system built for medical device startups — not an enterprise platform priced at $5K–$15K/mo. Pricing scales with user count and document volume.

  • 5 core QMS subsystems: doc control, CAPA, training, suppliers, complaints
  • Dual compliance: 21 CFR 820 (FDA) & ISO 13485 (international)
  • Training records management with completion tracking
  • Supplier qualification & audit scheduling
  • Complaint handling with trend analysis
  • Integrates directly with Control Tower dashboard

Quality system gaps discovered during acquisition due diligence can reduce deal value by $500K–$2M. QMS-Lite at $200–500/mo is insurance against that risk.

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AI-Powered

Predicate Finder

Included with services

  • Search FDA's openFDA database for predicate devices
  • AI-powered substantial equivalence analysis
  • Product code & regulation number lookup
  • 510(k) clearance history & decision summaries
  • Exportable comparison reports
  • Tri-lingual interface (EN/中文/한국어)
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Most Popular

Professional PM

$10–25K/mo

A dedicated PMP project manager runs your Control Tower dashboard, manages gate reviews, coordinates vendors, tracks FDA timelines, and delivers weekly status reports. Typical engagement: 12–18 months.

  • Everything in SaaS, plus:
  • Dedicated PMP project manager
  • FDA Communications Center (Q-Sub automation, MDUFA tracking)
  • US Agent representation (FDA requirement for foreign manufacturers)
  • Gate review management & weekly status reports
  • Regulatory submission oversight
  • Supplier coordination & testing lab management

Comparable US regulatory consultancies (Emergo, NAMSA, Greenlight Guru) charge $15–50K/mo for similar PM services — without a dedicated project dashboard. Our $10–25K/mo includes the full Control Tower platform.

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Market Entry

Entity Setup Tracker

$1K–5K or $200/mo

Guides US entity formation step-by-step and keeps compliance documents organized. One-time fee covers setup; monthly fee covers ongoing compliance tracking.

  • Delaware C-Corp formation — the structure US acquirers expect
  • Oregon state registration, registered agent & EIN
  • US bank account coordination (required before paying FDA fees)
  • FDA establishment registration & US Agent designation
  • Labeling compliance tracking (US requirements differ from CN/EU)
  • Prerequisite for nearly every other service we offer

Law firms typically charge $5K–$15K for incorporation, registered agent, and FDA registration. Our tracker provides the same organizational framework at $1K–$5K — a fraction of attorney fees.

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Full Service

Enterprise

$50–200K+

End-to-end 510(k) project management: regulatory strategy, predicate research, testing oversight, submission preparation, and investor-ready documentation. Project-based pricing.

  • Everything in Professional, plus:
  • Regulatory strategy & pathway selection
  • Automated 17-item RTA self-check, SE decision flow & DHF readiness
  • US entity formation assistance
  • End-to-end 510(k) management
  • Investor-ready documentation & due-diligence package

Includes everything in Professional PM plus hands-on regulatory work — predicate device analysis, testing protocols, 510(k) dossier drafting, and FDA submission management.

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Inside the Control Tower

Our 17-tab dashboard manages every aspect of your FDA journey — from a guided setup wizard through dual-track development, FDA communications automation, and team collaboration.

▶ 510(k) Lifecycle Walkthrough

See how the Control Tower guides a medical device from Pre-Sub through FDA clearance — step by step.

Dual-Track Overview
Step 1 of 8

Dual-Track Overview

The Control Tower organizes your 510(k) program into two parallel tracks: Technical (testing, V&V, prototypes) and Regulatory (Pre-Sub, 510(k) filing, FDA clearance). Both progress simultaneously — the Dual-Track view shows every milestone at a glance.

Pre-Sub Filing
Step 2 of 8

Pre-Sub Filing (M+0)

Your first regulatory action: file the Pre-Submission (Q-Sub) package with FDA at Month 0. This requests formal feedback on your predicate device selection, testing protocol, and software classification before committing resources.

FDA Feedback
Step 3 of 8

Pre-Sub Meeting & FDA Feedback (M+2)

The Regulatory tab tracks your Pre-Sub timeline: Day 0 filing → Day 15 FDA acknowledgment → Day 30 meeting scheduled → Day 70–75 written feedback. FDA's response letter becomes the blueprint for your testing plan and 510(k) strategy.

Gate Reviews
Step 4 of 8

Gate Reviews (M+3–5)

While testing runs (bench testing, clinical validation), the Gate System ensures quality checkpoints are met before advancing. Gates block progression until criteria are satisfied — preventing premature submissions.

MDUFA Clock
Step 5 of 8

510(k) Filed → MDUFA Clock Starts (M+6)

When the 510(k) is submitted, the MDUFA 90-day review clock starts on the Timeline. The badge shows "Day X / 90" and changes color: green (<60 days), amber (60–89), red (≥90). A real-time FDA review countdown.

FDA Review
Step 6 of 8

FDA Review in Progress (M+7–8)

The radial clock gauge shows Day 45 / 90 — halfway through FDA review. The clock progresses: RTA Screening (Day 1–15) → RTA Cleared (15–60) → Substantive Review (60–89) → Decision Pending (90+). An AI request pauses the clock.

Clearance
Step 7 of 8

510(k) Clearance (M+9)

FDA issues a Substantially Equivalent (SE) order — your device is cleared! Module A is market-ready while Module B continues its parallel regulatory path. Cash Runway and Budget tabs reflect post-clearance revenue projections.

Module B
Step 8 of 8

Module B Parallel Track (M+12–18)

The power of dual-track: while Module A generates revenue post-clearance, Module B progresses through its own Pre-Sub → testing → 510(k) → clearance cycle. Every tab updates to show both modules' combined status — the full 510(k) lifecycle in one Control Tower.

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.

Gate System

Gate System

Phase-gate reviews with criteria checklists — Go/No-Go decisions recorded with stakeholder inputs and conditions.

Risk Dashboard

Risk Dashboard

ISO 14971 risk matrix with severity, probability, and color-coded risk levels — track mitigations from identification to closure.

FDA Communications

FDA Communications Center

Q-Sub cover letter generator, 17-item RTA self-check, MDUFA 90-day radial clock gauge (color-coded Day 15 RTA → Day 60 review → Day 90 decision, with clock-pause tracking), SE decision flowchart, plus a mini day-badge on the Timeline tab — all in one platform.

Budget

Budget Tracking

Planned vs. actual spend by category with automatic variance calculation — toggle between USD and CNY display.

Audit Trail

Audit Trail

21 CFR Part 11 compliant — every change timestamped with user, field, old value, new value, and detail description.

Actions

Actions / DHF / CAPA

Task board, Design History File tracker, Device Master Record tracker, and Corrective & Preventive Action log.

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.

🧙

Tri-lingual Setup Wizard

A guided 9-step wizard pre-populates your entire project dashboard — team roster, budget, milestones, suppliers, and risk register — in English, 한국어, 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 FDA's 90-day MDUFA review clock (Day 15 RTA screening → Day 60 substantive review → Day 90 decision target, with automatic clock-pause when FDA requests Additional Information) — nested inside your full project timeline — 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.

🔍

Predicate Finder

AI-powered search of FDA's openFDA database to identify predicate devices, analyze substantial equivalence, and generate comparison reports. Find the right predicate in minutes — not weeks of manual research.

📄

FDA Guidance Document Search

Search FDA's library of 2,700+ guidance documents — final and draft guidances for medical devices, software, cybersecurity, biocompatibility, labeling, quality systems, and clinical data. Integrated directly into Control Tower.

🏗️

QMS-Lite for Startups

A lightweight quality management system aligned to 21 CFR 820 and ISO 13485 — covering document control, CAPA, training records, supplier qualification, and complaint handling. Built for startups, not enterprise complexity.

🌐

Cross-Border Entity Setup

Step-by-step tracker for US market entry — Delaware C-Corp formation, Oregon state registration, registered agent, EIN, bank account, FDA establishment registration, and US Agent compliance.

Trusted by Medical Device Teams

"The Control Tower dashboard gave us complete visibility into our 510(k) timeline. We always knew exactly where we stood with FDA."

Medical Device Startup CEO Class II Respiratory Device

"Having a multilingual PMP who understood both our R&D team and US regulatory requirements was the difference between success and failure."

VP of Regulatory Affairs Cardiovascular Device Company

"The 510(k) Bridge strategy helped us secure seed funding at the right time — right after our Pre-Sub meeting when investor confidence was highest."

Co-Founder & CTO Digital Health Startup

Free Resources

Download our guides and start your FDA journey today.

📘

FDA 510(k) Pathway Guide

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

Download (English) 下载 (中文) 다운로드 (한국어)
📋

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) 다운로드 (한국어)
🔍

Search FDA Guidance Documents

Search FDA's library of 2,700+ guidance documents — final and draft guidances for medical devices, software, cybersecurity, biocompatibility, labeling, quality systems, and clinical data.

Search FDA Guidances
🎓

PMP Course

Free project management course with exercise answer key — our gift to help you build the management discipline every FDA submission requires.

Download (English) 下载 (中文) 다운로드 (한국어)
💰

Investment & Fundraising Guide

Term sheets, funding rounds, valuation methods, and the 510(k) Bridge strategy — everything medtech founders need to know about raising capital.

Download (English) 下载 (中文) 다운로드 (한국어)

Let's Talk

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

510k Bridge Logo
Email [email protected]
Location

Oregon, USA
Serving clients in the US, China and Korea.

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