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3D LifePrints achieves ISO 13485:2016 certification

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3D LifePrints, a leading 3D technology company providing innovative 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 industry-leading point-of-care model by launching a new range of patient-specific sterilizable 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 sterilizable devices within a Controlled Environment in one of 3D LifePrints’ embedded Hubs.  This innovation brings the timeline for delivery of these types of devices down from weeks to days.

“It has long been our goal to standardize our processes by adherence to this internationally recognized standard,” commented Henry Pinchbeck, CEO 3D LifePrints: “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 printed models of bones and skeletal structures on display in the Innovation Hub at Alder Hey Children’s Hospital, printed by 3D LifePrints (both Liverpool, UK).

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 organization maintains its quality and compliance levels specific to the design, manufacture and distribution of medical devices.

3D LifePrints’ primary focus is the supply of patient-specific 3D printed medical devices to organizations 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 advanced 3D printing hardware and a suite of software. The embedded nature enables the host institution to enjoy all of the benefits of having an ‘in-house’ service including ease of access to an engineer and immediate delivery of the devices.

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Davide Sher

Since 2002, Davide has built up extensive experience as a technology journalist, market analyst and consultant for the additive manufacturing industry. Born in Milan, Italy, he spent 12 years in the United States, where he completed his studies at SUNY USB. As a journalist covering the tech and videogame industry for over 10 years, he began covering the AM industry in 2013, first as an international journalist and subsequently as a market analyst, focusing on the additive manufacturing industry and relative vertical markets. In 2016 he co-founded London-based 3dpbm. Today the company publishes the leading news and insights websites 3D Printing Media Network and Replicatore, as well as 3D Printing Business Directory, the largest global directory of companies in the additive manufacturing industry.

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