3D LifePrints achieves ISO 13485 for its QMS

3D LifePrints, a 3D technology company providing solutions to the medical sector, 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 sterilisable Surgical Guides and Anatomical Models, whilst 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 sterilisable 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 recognised standard of excellence, ISO 13485:2016 ensures that an organisation maintains its quality and compliance levels specific to the design, manufacture and distribution of medical devices. 

Henry Pinchbeck, CEO said: “It has long been our goal to standardise our processes by adherence to this internationally recognised standard. 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.”

3D LifePrints’ primary focus is the supply of patient-specific 3D printed medical devices to organisations including hospitals, universities, and medical device manufacturers. Their current key Hubs include Alder Hey Children’s Hospital in Liverpool, Nuffield Orthopaedic Centre in Oxford, Wrightington Hospital in Greater Manchester and Leeds General Infirmary.

The company operates a unique operating model where the products are delivered as a service from embedded Hubs within host institutions. The Point-of-Care service includes: bio-medical engineers; a range of 3D printing hardware and a suite of software.