Navigating the FDA 510(k) process can feel overwhelming—especially for startups or solo innovators without in-house regulatory expertise. That’s where I come in.

With hands-on experience leading full FDA 510(k) submissions—from initial strategy to final clearance—I provide practical, actionable support tailored to Class II medical devices, including radiology, oncology, and software-based systems.

This service is designed to take the guesswork out of regulatory compliance. Depending on your needs, I can assist with:

• Regulatory pathway analysis & classification
• Pre-Submission (Q-Sub) preparation
• Complete 510(k) documentation (SDS, SRS, risk management, labeling, etc.)
• Coordination of verification & validation (V&V) planning
• Submission formatting, eSTAR support, and FDA correspondence

Whether you're just starting or already mid-process, I’ll work with you to keep your project moving and aligned with FDA expectations. Let's connect!