Regulatory Compliance
Quality, Safety, and International Standards
At OpenSonics, quality is non-negotiable. Every system we design is rigorously tested and built with a solid quality process to support teams aiming for clinical applications.
We proudly adhere to:
Directive 2014/30/EU
(Electromagnetic Compatibility)
Standard EN 61326-1
(Electrical Equipment Safety)
Directive EU 2015/863
(Medical Device Safety and Performance)
Directive 2014/35/EU
(Low Voltage Safety)
IEC 61010-1
(Laboratory Equipment Safety)
Our commitment to regulatory compliance ensures that your research is supported by safe, reliable, and internationally recognized technology. For documentation or further inquiries, contact our technical support team.
For more information, get in touch with us
Our mission
At OpenSonics, our mission is to empower researchers and startups by providing tailor-made ultrasound solutions rooted in TPAC’s heritage