Our Mission

Our mission is to design, source, import, and distribute medical devices in strict accordance with applicable FDA regulations, ISO 13485 quality management system requirements, and other relevant international standards governing medical devices.

We are committed to maintaining a robust Quality Management System that ensures risk-based design controls, supplier qualification and oversight, process validation, traceability, documented change control, and continuous improvement across the entire product lifecycle. Through disciplined quality planning and regulatory compliance, we aim to ensure the safety, performance, and reliability of every medical device we place into the healthcare system.

As part of our long-term strategic vision, OttoMed is actively expanding into advanced and robotic-assisted medical device technologies. We are focused on integrating automation, precision engineering, and next-generation medical robotics to support improved clinical efficiency, enhanced patient outcomes, and the evolving needs of modern healthcare environments.

Operating from both the East and West Coasts of the United States, we support nationwide distribution with validated logistics and controlled supply chains, enabling consistent product availability while maintaining full regulatory accountability.

Our mission is guided by a forward-looking commitment to innovation, regulatory excellence, and quality-driven growth—ensuring OttoMed remains aligned with the future of medical technology while meeting today’s highest compliance standards.