Padd® -- a quick and painless diagnostic device which measures peripheral blood circulation -- has achieved its CE mark and ISO certification 13485:2003, an internationally recognised quality management standard.
The CE Mark shows that the product conforms with the essential requirements of European Union directives and is approved for sale in Europe.
The International Organisation for Standardisation certification confirms that the makers of Padd® are authorised to design and manufacture medical devices.
The accreditations mark a significant milestone for Dialog Devices -- the creators of Padd®. CEO Jody Brown said: "I am delighted that the company has successfully reached this key milestone with tremendous support from the Department of Health and the National Health Service in the UK where the early diagnosis of peripheral arterial disease will benefit patients and reduce the cost of managing cardiovascular disease and long-term conditions."
Dialog Devices, based at Loughborough University's Innovation Centre, was founded on research carried out at the University. It now employs an eight-strong team comprising business, marketing and technical expertise.
The Padd® technology can be used to diagnose peripheral arterial disease (PAD) -- an early symptom of heart disease and stroke, affecting 90 million people worldwide.
Current screening for PAD is time-consuming and requires skilled operators. Padd® offers rapid, simple and robust assessment of blood circulation in the lower limbs and feet.
An infra-red probe, no more powerful than a TV remote control, is held to the foot for a couple of minutes to assess how well the blood supply adapts to forces of gravity caused by postural changes such as getting out of bed and standing up. The test is easy and safe to perform and ideal for busy vascular clinics and GP surgeries. Earlier diagnosis of PAD has the potential to save lives.
Earlier this year, Dialog Devices was a winner in an NHS competition to find new ways to combat long-term conditions. The Smart Solutions for Healthcare competition was delivered by TRUSTECH, the North West NHS Innovation Hub, an NHS organisation that aims to improve healthcare through the development of innovative products and services.
Dr Bryan Griffiths of TRUSTECH said: "Padd® provides an easy way to diagnose peripheral arterial disease within the community, without the need to refer patients to hospital. By allowing earlier diagnosis, it can also help to improve outcomes for patients and ultimately save on long-term treatment costs. Innovations like Padd have a major role to play in helping the NHS meet the challenges ahead."
The company's quality management system was audited and assessed by TUV SUD Product Service GmbH, one of the world's leading certification bodies.
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The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by University of Loughborough.
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