The extension certification enables Sphere to manufacture its diagnostic and monitoring medical devices, including its Proxima disposable patient-attached arterial blood analyser, at its manufacturing facility in Harston, Cambridge.
Sphere Medical’CEO Stuart Hendry said the successful completion of the audit and certification by TUV SUD validates the excellent quality management system they have.
"This scope extension is an important achievement and underpins our capability for commercial manufacture at our Harston facility," Hendry said.