Ocean Optics, Inc. has received ISO 13485:2016 certification for its Quality Management System, confirming the company’s compliance with internationally recognized standards for the design, manufacturing, and quality control of medical-device instrumentation. The certification, valid from August 26, 2025 to August 25, 2028, demonstrates that Ocean Optics has implemented a robust system aligned with regulatory requirements and best practices in the medical-device industry.
Issued by an accredited certification body, the audit verifies that Ocean Optics maintains effective processes for risk management, documentation, and product traceability throughout the lifecycle of its medical-device components. Achieving ISO 13485 positions the company to enhance product reliability, meet global regulatory expectations, and strengthen customer confidence in its medical-grade spectroscopic technologies.
