Cephasonics Successfully Completes ISO 13485 Audit with Zero Findings

​​BLAINE, Minnesota and SAN JOSE, California — May 28, 2026 --

Cephasonics, a provider of OEM quantitative ultrasound platforms and embedded ultrasound technologies for advanced medical devices, today announced the successful completion of its 3rd ISO 13485 audit with zero nonconformities, zero areas of concern, and zero opportunities for improvement identified by the auditor.

​Cephasonics also received updated ISO 13485 certification covering both its manufacturing facility in Blaine, Minnesota and its engineering support and development office in San Jose, California. The successful audit reinforces Cephasonics’ ongoing commitment to quality, regulatory compliance, and continuous operational excellence as the company expands support for OEM partners developing next-generation medical technologies.

The audit included a comprehensive review of Cephasonics’ business and quality management processes supporting both manufacturing operations and design and development activities. In addition, the audit evaluated the companywide implementation and use of the Qualio online quality management system, which is utilized across the organization to manage and track manufacturing records, product documentation, inventory controls, and development projects in support of Cephasonics’ ISO 13485-certified operations.

“Achieving an audit result with zero findings across both our manufacturing and engineering operations reflects the strength of our quality systems and the dedication of our entire team,” said Richard Tobias, Founder and CTO of Cephasonics. “As more medical device companies integrate ultrasound into their platforms, our customers rely on us not only for advanced technology, but also for disciplined quality processes capable of supporting commercial medical device development and production.”

Cephasonics specializes in compact, scalable OEM ultrasound platforms designed for direct integration into medical devices and AI-enabled healthcare systems. The company’s technologies provide access to real-time unfiltered ultrasound data to support advanced applications including: AI-powered analysis and decision support Quantitative ultrasound measurement and telemetry Surgical and robotic navigation Therapeutic ultrasound applications Real-time procedural guidance and system interoperability Through its open software development environment and embedded ultrasound architectures, Cephasonics enables medical device manufacturers to incorporate ultrasound directly into innovative products rather than relying on traditional standalone ultrasound consoles. The company’s ISO 13485-certified quality management system supports both design and manufacturing activities for OEM ultrasound systems intended for integration into a broad range of medical devices and healthcare technologies.

About Cephasonics Cephasonics is an OEM ultrasound technology company focused on quantitative, AI-ready ultrasound platforms for integration into advanced medical devices. Cephasonics provides scalable hardware, software, and development platforms designed to deliver real-time ultrasound data for imaging, navigation, telemetry, measurement, and AI-driven medical applications. The company’s technologies are optimized for embedded medical device applications requiring interoperability, compact form factors, and access to unfiltered ultrasound data.