ISO 14971 Risk Management
Complete Risk Management Files (RMF) including plans, hazard analysis, FMEAs, and reports that pass audits.
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Accepting New Clients in Albuquerque & Remote
Strategic Medical Device
Compliance & Consulting
Accelerate your path to market with audit-ready ISO 14971 risk management, ISO 13485 quality systems, and FDA 510(k) submissions.
Trusted by Innovative MedTech Companies
MEDIXA
NEUROTECH
PULSEBIO
CLEARPATH
Comprehensive Regulatory Solutions
We simplify complex regulations into clear, actionable strategies tailored to your device's specific needs.
ISO 13485 QMS
Gap assessments, SOP development, internal audits, and CAPA management to ensure full compliance.
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Strategic predicate selection, testing plans, and eSTAR preparation for successful FDA clearance.
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Years Experience
100%
Audit Success Rate
Global
Client Reach
Expertise You Can Trust
With over 20 years of industry experience, we don't just advise—we implement. Our approach is practical, lean, and designed to get your device to market faster without compromising safety or compliance.
- 95% First-Round Acceptance rate for submissions.
- Audit-Ready Documentation that stands up to scrutiny.
- Local Albuquerque Presence with global regulatory reach.
20+
Years Experience
60+
Projects Delivered
100%
Client Satisfaction
6mo
Faster Time-to-Market
Ready to Streamline Your Compliance?
Book a free consultation to discuss your device, timelines, and regulatory strategy.
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