TUV SUD Product Service has granted a formal extension certification to Sphere Medical to include production of medical monitoring systems into its existing EN ISO13485 for design and development.
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.