Author: Novarum DX
A smartphone diagnostic specialist 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, Novarum’s revolutionary image-capture technology enables the accurate reading of diagnostic tests using nothing more than 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 eco-system.
Achieving ISO 13485:2016 certification provides assurance that Novarum continues to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Certification to this new standard 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.
Dr Christie added: “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 some of the diagnostic industry’s biggest players and the business also works with smaller, more niche specialists to develop new approaches to target and treat infectious disease, toxicology and auto-immune disease.