Navigating FDA Compliance with Confidence

Sterling Medical Registration offers a full suite of regulatory services tailored to medical device manufacturers seeking FDA clearance and ongoing compliance. From initial submissions to post-market obligations, our team ensures your product meets all necessary standards for safe and lawful distribution in the U.S.

🔍 FDA 510(k) Submission

The 510(k) process is a critical pathway for bringing medical devices to market. We guide clients through every step—from compiling technical documentation to submitting the final file and responding to FDA inquiries. Our goal is to streamline your approval process and minimize delays.

🧾 U.S. Agent & Official Correspondent

Foreign manufacturers must appoint a U.S. Agent to interface with the FDA. We serve as your official correspondent, ensuring timely and accurate communication with regulators.

🏷️ Labeling Compliance

Proper labeling is essential for regulatory approval and user safety. We help design and format labels, symbols, instructions for use, and packaging that align with FDA requirements.

🏢 Establishment Registration & Listing

Once your device is cleared, we assist with registering your manufacturing facility and listing your product in the FDA’s official database—an essential step for legal marketing.

📋 Medical Device Reporting (MDR)

We support compliance with FDA’s electronic MDR rule (21 CFR Part 803), helping you report adverse events and malfunctions efficiently and accurately.