Tronics' US subsidiary now complies with the ISO 13485:2016 standard. This milestone recognizes the company's efforts to design, manufacture and sell MEMS products for diagnostic chips, in compliance with international standards specific to the medical devices industry.
Grenoble, France and Dallas, TX, USA – 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.
About Tronics Microsystems
Tronics Microsystems is a division of TDK's Temperature & Pressure Sensors Business Group that manufactures custom MEMS products and standard inertial sensors. Addressing high-growth markets relying on increasing miniaturization of electronic devices, the company provides custom and standard products especially to the industrial, aeronautics, security, and medical markets. Founded in 1997, Tronics is located in Crolles, near Grenoble (France) and in Dallas, Texas (United States), and has around 100 employees, most of them engineers and scientists. Following a tender offer ending January 2017, TDK Electronics AG (formerly EPCOS AG) now holds 74 percent of Tronics' shares.
* ISIN code: FR0004175099 ALTRO
About TDK Corporation
TDK Corporation is a leading electronics company based in Tokyo, Japan. It was established in 1935 to commercialize ferrite, a key material in electronic and magnetic products. TDK's comprehensive portfolio features passive components, such as ceramic, aluminum electrolytic and film capacitors, as well as magnetics, high-frequency, and piezo and protection devices. The product spectrum also includes sensors and sensor systems such as temperature and pressure, magnetic, and MEMS sensors. In addition, TDK provides power supplies and energy devices, magnetic heads and more. These products are marketed under the product brands TDK, EPCOS, InvenSense, Micronas, Tronics and TDK-Lambda. TDK focuses on demanding markets in the areas of information and communication technology and automotive, industrial and consumer electronics. The company has a network of design and manufacturing locations and sales offices in Asia, Europe, and in North and South America. In fiscal 2018, TDK posted total sales of USD 12 billion and employed about 103,000 people worldwide.
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