We streamline the entire 510(k) process, from preparing your submission file to managing official FDA correspondence. Our team ensures your documentation is complete, accurate, and positioned for a smooth clearance pathway.
As your designated U.S. representative, we act as the direct link between your company and the FDA. This service provides peace of mind by ensuring timely communication, regulatory compliance, and a trusted presence in the U.S. market.
Your product’s labeling is is crucial for public health. We help you design and refine labels, symbols, Instructions for Use (IFUs), and packaging that meet FDA requirements while remaining clear and user-friendly for healthcare professionals and patients.
We will assist you with registering your facility and listing your medical devices in the FDA database. This ensures your products are recognized as compliant and ready for distribution in the U.S. healthcare market.
Our experts assist with electronic MDR submissions, helping you meet FDA requirements for reporting adverse events and device malfunctions. This protects patients, safeguards your reputation, and demonstrates your commitment to safety.
We support the implementation and maintenance of FDA Quality Management System Regulation (QMSR) under 21 CFR Part 820. This ensures your operations meet the highest standards of quality, consistency, and regulatory compliance.