Full FDA 510(k) Submission Support – Class II Devices
Helping startups streamline your FDA 510(k) process for radiology, oncology, and software devices.
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 & classification
- Regulatory strategy & gap analysis
- 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!
Choose a pricing plan
FDA Strategy Call (30 min)
$99
• Ideal for early-stage clarity
• 30-minute 1:1 consultation
• Initial regulatory pathway guidance
• High-level feedback on device & readiness
• Clear next steps to move forward confidently
• 30-minute 1:1 consultation
• Initial regulatory pathway guidance
• High-level feedback on device & readiness
• Clear next steps to move forward confidently
Pre-Sub Review & Feedback
$999
• Detailed review of device & documentation
• Identification of gaps in your 510(k) approach
• Written feedback with prioritized recommendations
• Guidance on Submission readiness
• Actionable insights you can implement immediately
• Identification of gaps in your 510(k) approach
• Written feedback with prioritized recommendations
• Guidance on Submission readiness
• Actionable insights you can implement immediately
End-to-End 510(k) Strategy & Submission Support
$50,000
• End-to-end 510(k) regulatory strategy and submission planning
• Intended use, product requirements, and regulatory pathway alignment
• Design and software documentation guidance (requirements, risk management, V&V)
• Clinical workflow and product design alignment
• Risk-control and mitigation strategy development
• Verification and validation strategy, planning, and review
• Clinical/performance evidence strategy and FDA-ready presentation
• Review and refinement of key submission documentation
• eSTAR submission preparation and consistency review
• FDA interaction and submission support
• Support through initial submission and FDA review, within agreed project scope
• Intended use, product requirements, and regulatory pathway alignment
• Design and software documentation guidance (requirements, risk management, V&V)
• Clinical workflow and product design alignment
• Risk-control and mitigation strategy development
• Verification and validation strategy, planning, and review
• Clinical/performance evidence strategy and FDA-ready presentation
• Review and refinement of key submission documentation
• eSTAR submission preparation and consistency review
• FDA interaction and submission support
• Support through initial submission and FDA review, within agreed project scope