FDA Submission for Your SaMD Product

✅ Are You Ready for FDA Submission for Your SaMD Product?
Bringing a Software as a Medical Device (SaMD) product to market is a significant milestone—but regulatory readiness is just as critical as product development.
At D2R Global Consulting, we help companies navigate the FDA submission process with clarity and confidence. One of the most overlooked challenges? Preparing the required software documentation.
Here’s what you need from a software perspective for a successful FDA submission:
📘 Core Software Documentation Includes:
🔹 Documentation Level Evaluation
🔹 Software / Firmware Description
🔹 Risk Management File
🔹 Software Requirements Specification (SRS)
🔹 System and Software Architecture Design (SAD) Chart
🔹 Software Design Specifications (SDS) (for Class C software)
🔹 Software Life Cycle Process Description
🔹 Verification & Validation (V&V) Testing Reports
🔹 Software Version / Revision History
🔹 Unresolved Software Anomalies
These documents demonstrate design control, risk mitigation, and lifecycle management—all essential for compliance under FDA’s eSTAR template.

💡 How D2R Can Help:
🧠 Expert guidance on document structure and content
🛠️ Hands-on support to prepare submission-ready packages
📄 eSTAR-formatted documentation aligned with FDA expectations
📈 Strategic advice from design to regulatory approval

🎯 Whether you’re preparing your first 510(k) or expanding globally, D2R is your trusted partner for SaMD regulatory success.