Domico Med-Device is registered with the U.S. Food and Drug Administration (FDA) as a manufacturer, contract manufacturer, and specification developer. This registration signifies our adherence to the FDA’s Quality System Regulations (QSR), which govern the design, manufacture, and distribution of medical devices in the United States.
We are ISO 13485:2016 certified, demonstrating our commitment to maintaining a comprehensive quality management system that ensures consistent design, development, production, and delivery of medical devices. This certification underscores our focus on meeting regulatory requirements and enhancing customer satisfaction through continuous improvement
Our Commitment to Continuous Improvement
Domico Med-Device is dedicated to fostering a culture of quality and continuous improvement. We regularly conduct internal audits and engage in training programs to ensure compliance with regulatory standards and to identify opportunities for process enhancements. Our quality management system is designed to adapt to evolving industry requirements, ensuring that we consistently meet the needs of our clients and the healthcare community.
Compliance with International Standards
In addition to FDA and ISO certifications, Domico Med-Device complies with several international standards to ensure the safety and effectiveness of our products.
Discover the Full Range of Our Capabilities
With our FDA registration, ISO certifications, and adherence to international standards, you can trust that we meet the highest regulatory requirements. Reach out today to learn how our accreditations ensure the safety and effectiveness of the products we deliver.
