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Toumaz receives ISO 13485:2003 medical device quality management certification
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Toumaz Technology
: 24 January, 2008 (New Product) |
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Toumaz Technology has received ISO 13485:2003 certification for the company’s quality management system. |
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ISO 13485 is the regulatory standard for the international medical industry and is closely related to ISO 9000. Toumaz was assessed and certified as meeting the requirements of the standard by independent body SGS, the world’s leading verification and certification body.
ISO 13485 is a regulatory requirement in a number of international markets for the manufacture of medical devices, and forms the cornerstone for the CE certification of medical products in the EU.
Meeting the ISO quality management standard is a milestone in the ongoing commercialisation of Sensium, Toumaz’s breakthrough ultra-low power wireless platform for the development of non-intrusive body monitors for healthcare and lifestyle markets. In November 2007, Toumaz took the top honours in the Electronics category of the prestigious Innovation in Engineering Awards – given by The Institution of Engineering and Technology – in recognition of the groundbreaking innovation of the Sensium as an enabling technology for medical applications.
Toumaz Technology’s chief operating officer and co-founder Keith Errey commented: “We are delighted that Toumaz has been awarded the important ISO 13485 certification, which demonstrates our absolute commitment to quality throughout the product cycle including the manufacture of medical devices, and which will offer significant benefits to our customers.”
The combination of ultra-low power wireless and signal processing in one small System-on-Chip (SOC) allows the economies of scale of the semiconductor industry to be harnessed to provide highly functional, robust, low cost, disposable and non-intrusive monitors for a wide range of healthcare applications.
The Sensium sensor interface and transceiver platform enables real-time, intelligent, ultra-low power wireless monitoring of multiple vital signs – such as ECG, heart rate, body temperature, respiration and physical activity (via a 3-axis accelerometer) – and is currently being developed in both disposable and non-disposable body monitoring products.
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