Since 1995, SONOTEC has relied on a certified quality management system and has continuously refined it. Driven by its commitment to making the world a safer place, the company once again impressed during the recent audit with its clear processes, high level of transparency, and consistent focus on quality and customer satisfaction.
Special requirements such as the integration of the new headquarters, compliance with regulatory and customer-specific guidelines, additional control mechanisms for outsourced processes, and increasing international requirements for the validation of software and manufacturing processes were successfully implemented and positively evaluated. This underscores SONOTEC’s commitment to acting responsibly, independently, and sustainably.
The scope of the certification covers the development, manufacturing, and distribution of ultrasonic sensors and measurement technology, as well as solutions in the field of medical technology for contactless, non-invasive flow measurement and air bubble detection. The ISO 13485 standard plays a special role here: It is not only the basis for meeting regulatory requirements for existing customers, but also a central building block for the further expansion of activities in the future-oriented field of medical technology.
“The auditors confirmed fully compliant processes and smooth operations—a clear added value for our customers. For us, ISO 13485 is not only the basis for meeting regulatory requirements for existing customers, but also an important differentiator and a key building block for the further expansion of our activities in the medical technology sector,” says Jose Fernandes, Director of Quality at SONOTEC.
With precision, technological expertise, and a sense of responsibility, SONOTEC develops ultrasound solutions that build trust worldwide and guarantee the highest quality.
The certificates have been valid since the beginning of March 2026 and are valid until April 21, 2029.