Get FDA Approval 40% Faster. Guaranteed.
We've guided 200+ medical devices through FDA, EU, and China approvals. Our battle-tested strategies cut regulatory timelines in half while eliminating costly mistakes. Zero rejections in 3 years.
From Prototype to Market in 8 Months
Stop wasting 18+ months on regulatory delays. Our proven playbook gets startups FDA 510(k) clearance in record time—with first-time approval rates that beat industry average by 3x.
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Protect Your $50M Investment
Uncover hidden regulatory risks before they crater your deal. Our Rapid 72-Hour Red Flag Reports identify critical compliance gaps other consultants miss—keeping your valuation realistic.
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Dominate 3 Markets Simultaneously
Crack the US, EU, and China markets in parallel—not sequentially. Our multi-jurisdiction strategy delivers 3x faster global expansion while cutting compliance costs by 60%.
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Regulatory Affairs
Your fastest path to FDA clearance. We've submitted 300+ successful 510(k)s with a 98% first-time approval rate—eliminating the costly delays that derail most startups.
Learn More →Quality & Compliance
Pass your FDA audit on the first try. Our quality systems have withstood 500+ regulatory inspections without a single Warning Letter—protecting your market access and revenue.
Learn More →Marketing Strategy
Turn regulatory compliance into competitive advantage. Our market positioning strategies have helped clients secure $500M+ in Series B funding by de-risking their FDA pathway.
Learn More →Business Development
Close deals with Fortune 500 buyers. Our BD strategies open doors to hospital systems and distributors that ignore unproven medtech—accelerating your path to $10M ARR.
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Since 2017
12 Global Experts
US, EU, China Coverage
Our Experts Maintain Active Memberships & Certifications With
Meet The Experts Behind Your Approval
When you hire KMax, you don't get a junior associate. You get direct access to industry veterans who have sat on both sides of the regulatory table.
Principal Regulatory Consultant
Former FDA Reviewer (CDRH)
15+ years of experience. Specializes in 510(k) clearances for complex active implantables and software-driven devices. Has successfully negotiated over 50 Pre-Subs.
Director of China Operations
Ex-NMPA Liaison
Based in Beijing. Fluent in Mandarin and English. Expert in navigating the NMPA's changing testing standards and clinical evaluation reports (CERs).
Senior Quality Auditor
RABQSA Lead Auditor
20+ years in Quality Assurance. Has led over 200 Mock Audits for ISO 13485 and MDSAP. Specializes in remediation of Warning Letters and 483s.
The $5M Save: How We Caught What the "Big 4" Missed
A top-tier VC firm was 48 hours away from closing a Series A round for an "FDA-Ready" AI diagnostics company. They hired KMax for a final Rapid Red Flag check.
The Finding
The startup claimed 510(k) exemption based on outdated guidance. Their software actually required a De Novo submission—adding 18 months and $2M to the roadmap.
The Outcome
The VC renegotiated the valuation based on our timeline analysis, increasing their equity stake by 15% and ring-fencing funds for regulatory remediation.
72h
Turnaround Time for
Red Flag Reports
Stop Burning Cash on Regulatory Delays
Every month of delay costs you $250K in lost revenue. Get your FDA clearance roadmap in 48 hours—free strategy session reveals exactly how to slash your time-to-market.