Integrated Quality. Assured Compliance. Global Reach.
FDA GMP & ISO 13485 QMS Solutions for Medical Devices
Achieving compliance in the medical device industry requires a robust Quality Management System (QMS) that aligns with international and country specific regulations. At RegHelps, we specialize in developing and implementing QMS solutions that meet the stringent requirements of FDA Good Manufacturing Practices (GMP) under 21 CFR Part 820 and the globally recognized ISO 13485:2016 standard. Our services are designed to help manufacturers streamline their operations, reduce non-conformities, and ensure product safety and effectiveness from design to post-market surveillance. Whether you’re preparing for a facility modification including shop floor layout, FDA inspection, or ISO certification, our team of regulatory experts is here to guide you every step of the way.
Our Approach to Building a Compliant QMS
At I3CGLOBAL, we take a structured and regulatory-driven approach to building a Quality Management System (QMS) that meets the requirements of FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR. Whether you’re a startup or an established manufacturer, our experts tailor the QMS to your device class, risk level, and market goals.
We don’t just deliver documents — we build systems that work for audit readiness, regulatory approvals, and long-term operational efficiency.
Our proven methodology ensures:
QMS /GMP related FAQ’s
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
