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Medical equipment manufacturer granted licence extension

23 November 2011
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Medical equipment manufacturer granted licence extensionThe task of improving manufacturing processes may be taken up by those involved in work to make new blood-testing devices, after a Cambridge-based company was granted a licence extension to start producing them.

Sphere Medical has received an extension of its EN ISO13485 licence for design and development from Notified Body TUV SUD Product Service GmbH.

This means it can start producing its Proxima disposable patient-attached arterial blood analyser, which may create opportunities for those involved in improving manufacturing processes to work to maximise output and safety.

Chief executive of the firm Dr Stuart Hendry said: "This scope extension is an important achievement and underpins our capability for commercial manufacture at our Harston facility."

He said the news was an endorsement of the "excellent" quality management system it has in place.

The company produces equipment designed to test blood conditions such as gas, glucose and drug levels in real-time, but with laboratory accuracy.

Such swift information enables doctors to make rapid decisions about patient care.
 ADNFCR-3058-ID-801219734-ADNFCR
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