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


Sarissa has developed SMARTChip which will deliver a step change in biosensor performance enabling new diagnostic applications not previously possible. This ground-breaking technology is already being trialled as a point of care diagnostic for stroke, the second highest cause of death in the developed world and the major cause of adult disability globally. Currently treating stroke costs the NHS £5.5bn annually with a further £5bn cost to the economy. There are no diagnostic tests to help clinicians and paramedics identify strokes resulting is high levels of misdiagnosis and delayed treatment. SMARTChip addresses this challenge. To meet forecasted demand Sarissa will need to automate its production process. Innovate UK has recognised the global opportunity and has awarded Sarissa and Aston University a 2yr Knowledge Transfer Partnership award to automate the production of SMARTChip. The project, also being supported by the MTC (part of the High Value Manufacturing Catapult, supported by Innovate UK), will deliver a highly scalable production line capable of producing millions of unit/yr.


SMARTChip production line.


SMARTChip will enable, for the first time, physiological information to be obtained to complement clinical assessment of conditions such as stroke, traumatic brain injury (TBI), heart attacks, limb ischaemia and foetal hypoxia. SMARTChip will thus allow such assessments to be made at the point-of-care (POC) setting.

A key advantage is the ability to rapidly detect biological markers of trauma or disease at levels too low to be measured by competitor technologies, and without the need for time-consuming sample preparation and laboratory analysis.


Quality Certification

We have 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.