Tronics’ US subsidiary certified to ISO 13485:2016 for medical devicesPublished on April 10, 2019
Tronics, a TDK Group Company that manufactures custom MEMS products and standard inertial sensors, announces that its US subsidiary located in Dallas, Texas, is now certified to the ISO 13485:2016 quality management standard for medical devices, following the comprehensive audit of its quality management system by a global quality assurance and risk management auditor. Compliance with this internationally recognized standard demonstrates Tronics’ ability to provide services tailored for the demanding applications of diagnostic chips.
“This new milestone in Tronics’ Corporate Quality Safety & Environment Strategy affirms our willingness to further meet the high requirements of the medical industry, and brings additional added value to our entire ecosystem in this field,” says Julien Bon, Chief Executive Officer of Tronics. “This is an expression of our continuous commitment to act as a responsible and reliable partner, and to enable safer and more effective BioMEMS technologies for diagnostic chips.”
ISO 13485:2016 is the internationally recognized standard for a quality management system (QMS) specifically for vendors of medical devices and related services. It confirms that the company consistently meets customer and applicable regulatory requirements. The standard incorporates the latest QMS practices, both reflecting the evolution in medical device technology and focusing on risk management associated with the safety and performance of medical devices.
In addition, both of Tronics’ facilities in Crolles, France, and Dallas, USA, conform to the ISO 14001:2015 Environmental Management standard, which reflects Tronics’ ability to reduce the impact of its activities on the environment. As a next step Tronics in France will complete certification to the ISO 50001:2018 Energy Management standard.
Both facilities have also passed an independent CSR Assessment Audit in 2018, underscoring Tronics’ commitment to key corporate social responsibility topics such as Labor, Occupational Safety and Environmental Protection. Moreover, the assessment confirms that Tronics conducts its business in conformance with Responsible Business Alliance (RBA) Code of Conduct, the TDK Code of Conduct and the 10 Principles of the UN Global Compact.