A Selective Network for Serious FDA Regulatory Consultants
We're onboarding a small, vetted cohort of consultants with proven 510(k) / De Novo track records to handle high-intent projects from MedTech teams already working inside Cruxi.
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Who This Network Is For
This is not a generic marketplace. We're curating a small group of experts who can step into complex projects quickly and confidently.
You're a good fit if:
This is probably not for you if:
Why Leading Consultants Choose Cruxi
We already have the deal flow. We're carefully selecting the right people to send it to.
Highest Quality Client Base
Companies on Cruxi have already invested in device classification, predicate analysis, and regulatory assessment. These are serious, funded projects with clear timelines—not tire-kickers.
Zero Platform Fees, Forever
No commissions, subscriptions, or transaction fees. You keep 100% of what you earn.
Complete Project Intelligence
Before you engage, see the complete picture: device classification, predicate analysis results, regulatory assessment findings, and exactly which workflow steps are done. Communicate with confidence, not guesswork.
Your Time, Your Terms
Control your visibility, set your rates, choose your projects. Work when you want, with who you want. No obligations.
Professional Dashboard
Track conversations, response times, engagement rates, and project metrics. Build your reputation with verified credentials.
Work Together Directly
Connect with the client directly via their contact information or Cruxi live chat. Handle contracts, NDAs, payments, and project management your way. Cruxi simply facilitates the connection.
Verified Partner Network
We are opening our Verified Partner Network to a select group of independent consultants.
This is not a traditional full-time job. It is an application to receive priority lead routing from the industry's highest-traffic regulatory ecosystem.
How You Get Clients (The Dual-Engine Model)
By verifying your credentials with Cruxi, you gain visibility in two exclusive areas:
The In-App Workflow (The "Silver Platter" Handoff)
The Process: Cruxi users utilize our AI to handle the heavy lifting: Device Intake → Classification → Predicate Analysis → eSTAR Drafting → RTA Packaging.
The Handoff: Once the technical documentation is prepared, users request a Human Expert for the final "Redline Review" and to manage FDA communications.
Your Advantage: You don't start from scratch. You receive a client with a 90% complete eSTAR draft, allowing you to focus on high-value strategy and final submission management.
The #1 Ranked Public Directory (High Volume)
Leverage our SEO dominance. Your profile will be featured in our public directory, capturing the massive volume of organic search traffic we drive daily.
Partner Benefits
Zero Commission (Beta)
Keep 100% of your billable rate on initial matched projects.
Partner Technology Stack
All Verified Partners receive a Lifetime 50% Discount on Cruxi's professional tools, including our AI 510(k) Modification Assessment Engine—giving you a competitive edge over manual consultants.
Cruxi's Market Position
Focused on FDA Submissions
Cruxi is focused 100% on FDA submissions. Our content, tooling, and workflows are built for 510(k), De Novo, and PMA — which means the teams who find us are usually already planning or preparing a submission, not browsing casually.
How the Network Works
A streamlined, professional marketplace designed for serious regulatory experts
Apply With Your Track Record
Sign in and complete your professional profile: submission experience (510(k), De Novo, PMA), device types, certifications, and typical engagement model. Every application is manually reviewed. We prioritize consultants with documented experience and cap the number of profiles in each specialty.
Get Matched to Active Submission Projects
Companies already working inside Cruxi discover consultants by expertise and current workload. Initial outreach happens through Cruxi live chat, with anonymized but detailed project context.
Engage in Direct Conversation
Review the project details and Cruxi workflow progress. Discuss scope of work, pricing, timeline, and deliverables directly through live chat. Respond promptly for best results.
Gain Full Project Access
When you and the client agree to work together, you receive complete access to their Cruxi project workspace. Work directly in the platform to review, edit, and manage all submission sections—classification, predicate analysis, regulatory assessment, eSTAR drafting, and final packaging.
Work Together Directly
Connect with the client directly via their contact information or Cruxi live chat. Handle contracts, NDAs, payments, and project management your way. Cruxi simply facilitates the connection.
Immediate Access to Potential Customers Through Live Chat
Every conversation through Cruxi's live chat includes comprehensive project intelligence, giving you the full context you need to engage effectively.
Unlike generic consultant platforms, Cruxi provides the regulatory context you need to engage accurately and confidently
The Numbers Speak for Themselves
Why Cruxi is Different
Cruxi isn't another consultant marketplace—it's the platform where FDA submissions happen. Companies don't come to Cruxi to find consultants; they come to prepare their submissions using our AI-powered workflow, comprehensive regulatory database, and FDA-compliant eSTAR editor.
The consultant network exists because teams using Cruxi often reach a point where they want a human expert to review and sign off before submission. By then, key steps are already done. You're not asked to "figure everything out from zero" — you're stepping into a structured workspace with classification, predicate analysis, regulatory assessment, and draft eSTAR sections already in place.
By the time they reach out, they've already:
- Completed AI-powered device classification with product code identification
- Analyzed dozens of predicate devices with substantial equivalence scoring
- Generated comprehensive regulatory assessments with RTA risk analysis
- Drafted multiple eSTAR sections using FDA-compliant templates
This means higher-value engagements for consultants. Instead of starting from scratch, you're providing strategic review, final polish, and expert validation on well-prepared submissions. More efficiency, better pricing power, happier clients.
Who We're Currently Accepting
To keep quality high, we are capping the network at ~100 active consultants. Current priority areas:
– 510(k) (Class II, especially SaMD / software)
– De Novo & breakthrough devices
– EU MDR + FDA dual-pathway experts
Regulatory Consulting Firms
Expand your client base with pre-qualified leads actively seeking FDA submission expertise.
Independent Consultants
Build your practice with a steady stream of project opportunities matched to your expertise.
RAC Certified Professionals
Showcase your credentials and connect with clients seeking certified regulatory affairs professionals.
14 Professional Tools. Completely Free.
Make Cruxi your daily operating system with tools that save 20+ hours per week
510(k) Exemption Checker
Instant exemption status check - saves 30 min per device
Special Controls Decoder
Decode Class II requirements - saves 2-3 hours
Safety Intelligence
Recalls + MAUDE + enforcement data - competitive intel
Standards Compliance
Required standards checklist with cost estimates
Regulation Q&A Chat
AIAsk any CFR question - get answers with citations
Predicate QuickCompare
Side-by-side 510(k) comparison with SE bullets
Plus 8 more professional tools: Evidence Planner, MDUFA Calculator, Risk Generator, Client Intake Wizard, Budget Estimator, Timeline Builder, and more
💡 These tools alone save consultants $10,000+ in subscriptions and 20-30 hours per week
Access instantly when you join the network
Ready to Be Considered?
We're currently onboarding a limited founding cohort of consultants across key specialties. Applications are reviewed based on actual submission experience and fit with the types of projects on Cruxi.
We prioritize:
– Proven 510(k) experience (cleared submissions)
– De Novo / SaMD / AI/ML regulatory expertise
– RAC certification or equivalent credentials
If accepted, you'll receive context-rich conversations from teams already preparing their FDA submissions in Cruxi — and you'll work with them directly on your own terms.
Free to apply · No platform fees · You keep 100% of client fees
The review process takes up to 4 weeks.