3D LifePrints
Medical 3D printing company 3D LifePrints has achieved ISO 13485:2016 certification for its Quality Management System, enabling it to expand its services to the medical sector.
The ISO 13485:2016 standard ensures that an organisation maintains its quality and compliance levels specific to the design, manufacture and distribution of medical devices.
Having received the certification, 3D LifePrints is launching a new range of patient-specific sterilisable surgical guides and anatomical models to complement its existing offering of custom-made medical devices.
3D LifePrints operates in a business model that sees product delivered ‘as a service’ from ‘embedded hubs’ within host institutions. Among the company’s current ‘hubs’ is Alder Hey Children’s Hospital in Liverpool; Nuffield Orthopaedic Centre in Oxford; Wrightington Hospital in Greater Manchester; and Leeds General Infirmary, while they also work with universities and medical device manufacturers. Its Point-of-Care service includes bio-medical engineers, a range of advanced 3D printing hardware, and a suite of software.
Now supplementing its range of services to the aforementioned organisations is the ISO 13485:2016 certification, which 3D LifePrints has always intended to achieve because of the additional opportunities it facilitates.
“It has long been our goal to standardise our processes by adherence to this internationally recognised standard,” commented 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.”
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