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QuantuMDx achieves ISO 13485: 2016 certification – the international hallmark of quality

ByEmily

Mar 23, 2018

Newcastle-based QuantuMDx Group has been awarded ISO 13485: 2016 certification – representing the highest standard of quality a medical devices company can achieve.

ISO 13485 is a quality system standard designed specifically for medical device companies and is commonly regarded as essential for accessing markets across the globe.

The ISO certification provides assurance that QuantuMDx’s products are being designed and developed to the highest quality, follow a user-centred approach and are subject to external quality reviews. It also signifies that a robust risk management system is in place and there is a company-wide commitment to improvement.

QuantuMDx Group is currently developing a range of innovative products including Q-POC™: a point-of-care, portable, molecular diagnostic analyser to diagnose a range of infectious diseases in under 20 minutes, depending on the complexity of the test. These include tuberculosis, chlamydia, gonorrhoea and HPV. The Q- POC™ also includes a portfolio of complementary diagnostics to initiate, optimise and monitor therapeutics.

Jonathan O’Halloran, Chief Scientific Officer, QuantuMDx Group said:

“We’re committed to developing the very highest quality products at QuantuMDx and as such we’re delighted to have ISO 13485: 2016 certification.

“It’s been a huge team effort to achieve certification of our quality management system, with everyone at QuantuMDx dedicated to providing excellence. Special thanks go to our quality team who have worked incredibly hard to make this happen.”

Jonathan added:

“The FDA and EU require all medical device development to be managed by an ISO 13485 quality system, so we’re now a big step closer to commercialisation of our QPOC™ diagnostic tool.”

For more information about QuantuMDx Group, go to: www.quantumdx.com

By Emily