ISO 13485 Certified
|
|
Cephasonics’ Quality Management System (QMS) is certified to ISO 13485:2016 for both design and manufacturing of ultrasound hardware, software, and systems. This certification covers our San Jose, California engineering design center and our Blaine, Minnesota manufacturing facility, ensuring that every stage of our process—from concept through production—meets the highest international standards for safety, reliability, and compliance.
In our most current audit, we passed with zero nonconformities, zero concerns, and zero findings for improvement across both our Minnesota manufacturing facility and our San Jose engineering design center. This outstanding result reflects the rigorous standards upheld by our quality team and reinforces our company-wide commitment to excellence.
At Cephasonics, we develop embedded, interoperable ultrasound platforms that empower medical device manufacturers to integrate real-time imaging, AI, and quantitative data directly into their systems. ISO 13485 certification is a foundational part of our business model, ensuring that every aspect of our design and manufacturing process supports the highest levels of safety, reliability, and innovation for next-generation medical devices.
If you’re developing a medical device and looking to add value with advanced ultrasound capabilities—including AI-powered imaging and quantitative measurement/telemetry—connect with us. Let’s explore how Cephasonics can help you accelerate innovation and enhance clinical value.
In our most current audit, we passed with zero nonconformities, zero concerns, and zero findings for improvement across both our Minnesota manufacturing facility and our San Jose engineering design center. This outstanding result reflects the rigorous standards upheld by our quality team and reinforces our company-wide commitment to excellence.
At Cephasonics, we develop embedded, interoperable ultrasound platforms that empower medical device manufacturers to integrate real-time imaging, AI, and quantitative data directly into their systems. ISO 13485 certification is a foundational part of our business model, ensuring that every aspect of our design and manufacturing process supports the highest levels of safety, reliability, and innovation for next-generation medical devices.
If you’re developing a medical device and looking to add value with advanced ultrasound capabilities—including AI-powered imaging and quantitative measurement/telemetry—connect with us. Let’s explore how Cephasonics can help you accelerate innovation and enhance clinical value.
