Quantum Imaging Ltd, the UK-based medical device company looking to help emergency room staffrule out heart attacks and other serious heart problems, has today announced it has been certified ISO13485 by the British Standards Institute (BSI).
The BSI has awarded Quantum Imaging the certificate for the design, development, manufacture, distribution and servicing of its medical devices. ISO 13485 is a standard specific to medical companies and recognises the implementation of excellent quality management systems to ensure the best business practices and consistent quality in both internal practices and customer support.
Dave Dimambro, Technical Director at Quantum Imaging said: “Maintaining high standards in both our products and staff and customer relationships is important to us and we recognise quality as one of our core company values. Our quality management system underpins everything we do from design and development to production of our medical devices. Receiving this certification puts us in great shape to gain the required CE and FDA approvals in the near future.”
Quantum Imaging Chairman, Robert Barr said: “We are delighted that BSI has certified the company to ISO13485 as this is the first milestone in developing a company committed to the very highest standards in the industry.”
With this certification Quantum Imaging Ltd has the recognised quality management systems in place to begin producing a range of innovative medical devices. The company’s first product, Quantum Vitalscan, is currently undergoing patient trials with preliminary findings expected later this year.
Quantum Vitalscan is a portable medical device that can scan a patient presenting with chest pain in less than 5 minutes, helping doctors to rule out acute cardiac conditions, such as a heart attack or severe heart disease. Vitalscan can be used in hospital A&E departments directly at a patient’s bedside and produces highly accurate 2D imaging maps of the patient’s heart.
Quantum Imaging originated out of the University of Leeds in 2014 to commercialise sensor technology developed in the university’s Quantum Information group and two completed clinical studies have provided strong evidence and the basis for further product development.