Expert in Medical Device Regulations, Medical Physics, and FDA 510(k) Consulting
👋 Hi, I’m Yinghua, a medical physicist and regulatory consultant with a passion for helping companies navigate the complex world of FDA 510(k) submissions, medical device software compliance, and DICOM troubleshooting.
With years of experience in medical physics, software development, and regulatory affairs, I specialize in simplifying the submission process for medical device startups, ensuring compliance with FDA regulations, and guiding teams through software validation, risk management, and technical documentation.
🔬 My Background & Expertise
- 🎯 Medical Physics & Medical Imaging – Deep expertise in DICOM, RTSTRUCT, and medical imaging software.
- 📜 Regulatory Consulting – Hands-on experience with multiple successful FDA 510(k) submissions.
- 🖥 Software Development & Compliance – Specialized in medical device software lifecycle (IEC 62304) and risk management (ISO 14971).
- 🎓 Education & Training – Passionate about teaching and sharing knowledge through my blog, YouTube channel, and consulting work.
I know firsthand how frustrating regulatory hurdles can be. That’s why I focus on efficient, practical solutions to help companies meet compliance requirements without unnecessary delays.
🚀 My Mission
My goal is to empower medical device companies and professionals by providing expert guidance on regulatory compliance, medical physics, and software development. Whether you’re working on a 510(k) submission, struggling with DICOM integration, or need help with risk management, I’m here to help.
🔹 My approach? Simplifying complex regulatory and technical processes so that you can focus on innovation and patient impact.
📺 Sharing Knowledge: My YouTube Channel
I believe in making regulatory and technical topics more accessible. That’s why I create educational content on FDA submissions, DICOM troubleshooting, and medical physics tips.
📌 Popular Videos:
✅ How to Write a Software Requirements Specification (SRS) for 510(k)
✅ Fixing RTSTRUCT Import Errors in MOSAIQ
✅ Understanding Radiation Exposure: How Much is Too Much?
🎬 Subscribe & Watch Here:
🔗 Check Out My YouTube Channel: www.youtube.com/@yinghuatao1865
📩 Let’s Connect!
I’d love to hear from you! Whether you need consulting, have questions, or just want to chat about medical physics and regulatory affairs, feel free to reach out.
📧 Email: [email protected]
📅 Book a Consultation: [My Scheduling Link]