Sarissa awarded certification to ISO13485:2016 for Stroke Diagnosis Biosensor SMARTChip
We have recently been awarded our Certificate of Registration for our comprehensive quality management system for the design and manufacture of medical devices under ISO 13485:2016 and EN ISO 13485:2016.
These relate to: “the design, development, manufacture and sales of in vitro diagnostic biosensors for measurement of purines in blood at point of care to assist management of medical conditions.”
With this certification we can ensure our quality management system enables the consistent design, development, production of medical devices that are safe for their intended purpose.
We are now actively working towards CE marking SMARTChip