Helping You Navigate the FDA 510(k) Submission Process with Confidence
Bringing a medical device to market requires navigating complex FDA regulations. With my expertise in medical physics, medical device software development, and FDA 510(k) submissions, I help startups and companies streamline their regulatory pathway, ensuring compliance and efficiency.
Why Work with Me?
✔ Experienced in 510(k) Submissions – Successfully completed multiple FDA 510(k) submissions from start to finish.
✔ Medical Device Software Expertise – Specialized knowledge in software contained in medical devices and off-the-shelf (OTS) software validation.
✔ Custom-Tailored Guidance – Whether you need full submission support or specific document reviews, I provide custom consulting services based on your needs.
Services Offered
📌 510(k) Submission Support
- Full preparation and submission of your FDA 510(k) application
- Gap analysis and strategy development to meet FDA expectations
- Guidance on regulatory pathways and submission types
📌 Software Documentation & Compliance
- Software Requirements Specification (SRS) writing and review
- Software Development Lifecycle (SDLC) documentation support
- Off-the-Shelf (OTS) software validation strategies
📌 Risk Management & Verification
- Development of Risk Management Files (per ISO 14971)
- Assistance with Verification & Validation (V&V) planning
- Review of Test Reports and Traceability Matrices
📌 DICOM & Medical Imaging Compliance
- Troubleshooting DICOM integration issues for FDA submissions
- Assistance with RTSTRUCT, RTDOSE, and RTPLAN validation
- Guidance on DICOM conformance statement preparation
How It Works
1️⃣ Initial Consultation – Let’s discuss your project and identify your regulatory needs.
2️⃣ Custom Proposal – I provide a tailored approach based on your requirements.
3️⃣ Execution & Support – Work together on document preparation, compliance, and submission.
💬 Ready to streamline your 510(k) submission?
📅 Schedule a Free Consultation Today
👉 [Book a Consultation] (link to scheduling page)
📩 Or email me at [[email protected]]