3D LifePrints, a Liverpool, UK-based 3D technology company, announces it has achieved ISO 13485:2016 certification for its quality management system (QMS).
The certification enables 3D LifePrints to expand its point-of-care model by launching a new range of patient-specific sterilizable surgical guides and anatomical models, while continuing to deliver its existing custom-made medical devices.
The certification is underpinned by 3D LifePrints’ Digital Platform Embedmed. It includes the design and manufacture of sterilizable devices within a controlled environment in one of 3D LifePrints’ embedded hubs. This innovation brings the timeline for delivery of these type of devices down from weeks to days.
An internationally recognized standard of excellence, ISO 13485:2016 is a stringent set of guidelines for the medical device industry. The standard ensures that an organisation maintains its quality and compliance levels specific to the design, manufacture, and distribution of medical devices.
“It has long been our goal to standardize our processes by adherence to this internationally recognised standard,” says 3D LifePrints CEO Henry Pinchbeck. “The formal certification of our QMS opens up considerable market opportunities for the business and is a clear signal to our customers of the importance we attach to quality assurance and patient care.”
Featured image: 3D medical models (Credit: 3D LifePrints)