Evolve Regulatory Strategies guides medical device innovators through FDA clearance with strategic insight born from firsthand experience.
Founded by Dora Suppes, CEO of UV ONE Hygienics—which successfully achieved 510(k) clearance for KnoxFog in just over three months on resubmission—we understand the challenges device companies face because we’ve navigated them ourselves.
We specialize in helping early-stage and growth-stage medical device companies secure FDA 510(k) clearance efficiently and cost-effectively. Our approach combines regulatory expertise with entrepreneurial pragmatism: we know what it’s like to manage limited resources, tight timelines, and unexpected testing challenges while driving toward commercial launch.
Our Services:
- 510(k) Submission Strategy & Preparation – From predicate selection to final submission
- Biocompatibility & Testing Guidance – Navigate ISO 10993 requirements and lab coordination
- FDA Communication Strategy – Pre-submissions, Q-subs, and deficiency responses
- Regulatory Project Management – Keep your clearance timeline on track
- Fractional Regulatory Leadership – Embedded expertise without full-time overhead
Whether you’re approaching your first 510(k) or expanding your product line, Evolve Regulatory Strategies provides the strategic guidance and hands-on support to move from development to market with confidence.
UV ONE Hygienics, Inc. KnoxFog™
FDA Cleared August 2025
K251068
Why Evolve?
I’m not just a regulatory consultant. I am also a CEO who’s lived your challenges.
I’m a medical device CEO who just navigated FDA 510(k) clearance for my own company—achieving clearance in 3 months after strategic resubmission.
You’re Navigating:
✓ Limited capital vs. regulatory requirements
✓ Investor pressure for speed to market
✓ Complex testing strategies and predicate selection
✓ FDA review cycles that drag on indefinitely
✓ Need for expertise without full-time overhead
Every month delayed is lost revenue and competitive advantage.
How We Can Help
The Evolve Difference
A Complete Regulatory Ecosystem
Regulatory success isn’t just about submission strategy—it’s about having the right expertise and resources at every stage. Through Evolve, you gain access to a curated network of specialists and established partnerships that accelerate your path to clearance.
Expert Consultant Network
Evolves team includes regulatory experts for complex challenges requiring specialized knowledge:
- Class III devices and PMA pathways
- Combination products and international submissions
- Software/AI medical devices and clinical evaluation
- Specific therapeutic specialties
Established Testing Network
Years of device development have created strong relationships with best-in-class providers:
- Biocompatibility and performance testing labs
- Sterilization providers (EtO, gamma, e-beam)
- Shelf life and packaging validation services
- EMC and software V&V facilities
The Evolve Advantage
You gain access to trusted partners with competitive pricing, faster turnaround times, and proven track records—without the markup of large consulting firms. When you work with Evolve, you’re not just hiring a consultant. You’re accessing a complete ecosystem built to accelerate FDA clearance.
Is Evolve Right For You?
We work with:
Track Record
UV ONE Hygienics – CEO & Co-Founder
What a Former Dancer Learned About FDA Clearance the Hard Way
THE EVOLVE REGULATORY STRATEGIES STORY Background "I'm a former professional dancer turned medical device CEO. When we started developing an anti-fog solution for surgical endoscopes, I knew FDA clearance would be complex and expensive. I wanted [...]