Client Intake Wizard

Streamline new client onboarding with a guided form that automatically generates device profiles, regulatory pathway assessments, and cost estimates. This free tool saves consultants 2-3 hours per client by automating the initial client intake and assessment process.

A structured intake ensures you capture device classification, intended use, and predicate strategy early so 510(k), De Novo, or PMA pathway and cost estimates align with FDA expectations and reduce rework later.

How It Works

The Client Intake Wizard guides clients through comprehensive intake:

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Guided Questionnaire: Step-by-step form that collects device information, intended use, current development stage, regulatory history, and client goals through structured questions.
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Device Profile Generation: Automatically creates comprehensive device profiles including device name, classification, product code, regulation number, and key characteristics based on client responses.
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Regulatory Pathway Assessment: Analyzes device information to recommend appropriate regulatory pathways (510(k), De Novo, PMA, etc.) with rationale and requirements.
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Cost Estimation: Generates initial cost estimates including FDA fees, testing costs, consulting fees, and timeline estimates based on device complexity and regulatory pathway.
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Client Report Generation: Creates professional intake reports with device profile, pathway recommendation, cost estimate, and next steps for client review.

What It Does

This tool generates comprehensive client intake packages:

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Device Profile: Complete device profile with classification, product code, regulation number, and key characteristics
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Pathway Recommendation: Regulatory pathway assessment with rationale, requirements, and timeline estimates
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Cost Estimate: Initial cost breakdown including FDA fees, testing costs, and consulting fee estimates
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Next Steps: Actionable next steps and recommendations for moving forward with regulatory strategy
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Exportable Report: Professional PDF client intake report with your branding that can be shared with clients

⏱️ How It Saves Time

Saves 2-3 hours per client by automating client intake:

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Automated Profile Creation: Eliminates 1-2 hours of manually creating device profiles and organizing client information
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Pathway Assessment: Saves 30-60 minutes of researching and assessing appropriate regulatory pathways
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Cost Estimation: Automates 30-60 minutes of calculating fees, testing costs, and creating cost estimates
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Report Generation: Provides ready-made intake report structure, saving 30-60 minutes of document creation

ROI: for FDA 510k Consultants onboarding 10+ new clients per month, this tool saves 20-30 hours monthly while ensuring consistent, professional client intake.

Perfect For

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FDA 510k consultants onboarding new clients and performing initial regulatory assessments
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Firms providing initial consultations and regulatory strategy services
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Regulatory teams standardizing client intake processes and documentation
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FDA 510k consultants providing quick assessments and cost estimates for potential clients

Get Free Access to Client Intake Wizard

This tool is completely free for verified FDA 510k consultants in the Cruxi network. Join thousands of regulatory professionals who use our tools to save 20+ hours per week.

Join 510k Consultant Network (Free)

✓ No subscription fees • ✓ All 15 tools included • ✓ Export with your branding