Dora Suppes

About Dora Suppes

I help medical device companies navigate FDA 510(k) clearance through hands-on regulatory strategy, testing management, and problem-solving expertise.Recent Success: In August 2025, I achieved FDA 510(k) clearance (K251068) for a Class II medical device used in surgical and diagnostic applications. I personally managed every aspect of the regulatory process—from biocompatibility testing across five endpoints to direct FDA reviewer communication.What I Bring to Your Company:Regulatory Expertise • Complete 510(k) submission strategy and execution • Biocompatibility testing (ISO 10993) including complex cytotoxicity resolution • Sterility, bioburden, and endotoxin testing program management • Performance testing design and execution • FDA correspondence and technical response • Predicate device strategy and substantial equivalence demonstrationReal-World Problem Solving When our initial 510(k) submission revealed strategic flaws, I took ownership, identified the issues, and made the difficult decision to withdraw and resubmit. I personally coordinated with cytotoxicity specialists to develop a justification strategy the FDA accepted. The resubmission achieved clearance in just over three months.Business Perspective As a CEO who has navigated the regulatory pathway, I understand both the technical requirements and business pressures. I solve regulatory challenges with timeline and budget realities in mind.What I\'m Looking For: I\'m available for contract, fractional, or full-time remote consulting roles helping medical device companies achieve FDA clearance. Whether you\'re a startup preparing your first 510(k) or an established company needing regulatory support, I bring practical, battle-tested expertise.Current Focus Areas: • 510(k) submission preparation and strategy • Biocompatibility and sterility testing coordination • FDA communication and deficiency response • Testing protocol development • Regulatory project managementLet\'s connect if you\'re navigating FDA pathways or know companies that need regulatory expertise.

Experience

1. Chief Executive Officer

   Uv One Hygienics

   Apr 2020 — Present · Phoenix, AZ, US