New ISO standard secured for Novarum medical device

Smartphone diagnostic specialist, Novarum DX, has been accredited with ISO 13485:2016 certification for Medical Device Quality Management Systems (QMS).

Novarum DX transitioned from ISO 13485:2003, the internationally recognised Medical Device Quality Management System standard, to the new ISO 13485:2016 standard with zero non-conformances, ahead of the transition deadline in March 2019. To achieve certification, Novarum embarked upon a rigorous six month preparation period, followed by an independent review of their system processes and project documentation.

Part of BBI Solutions, who reported on the story, Novarum’s image capture technology enables the accurate reading of diagnostic tests using a smartphone. Test results can be recorded using a mobile app from the point of care, and the results are shared securely with healthcare professionals online, as part of a connected ecosystem.

ISO 13485:2016 certification is also a move to greater alignment with the Food and Drug Administration’s (FDA) quality system regulations, which governs how the US medical device markets operate.

Dr Alasdair Christie, Novarum’s Head of Regulated Product, said “Ensuring we have best-in-class quality management systems in place creates a robust platform to safely support ongoing innovation. This enables us to continue to develop market-leading mobile medical apps for our clients, in a compliant and secure environment…The US market is an important territory for Novarum and the new ISO certification reflects upon the FDA’s quality management system principles – enabling our continued alignment with this key market.”

Novarum’s smartphone reader solutions are used by the diagnostic industry to develop new approaches to target and treat infectious disease, toxicology and auto-immune disease.

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