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PrinterPrezz Gains ISO 13485:2016 Certification

PrinterPrezz has achieved ISO 13485:2016 Certification for Quality Management Systems for medical devices. The company has met regulatory standards for fabrication and 3D printing of titanium, non-titanium metals and advanced resin and plastic non-active implantable and non-implantable medical devices, associated components and surgical tools.

Shri Shetty, CEO of PrinterPrezz, said, “Designing and implementing a QMS and achieving ISO 13485:2016 Certification are important milestones for our company that reflect our emphasis on safety and providing high-quality devices. I am proud of the collaborative efforts of our team which underscore our commitment to supporting our customers, as together we revolutionize the way advanced medical devices are developed and brought to market.”

Serving the orthopedic industry, PrinterPrezz’s Medifacturing™ approach employs a suite of 3D printers, 3D manipulation software and 3D scanners as well as advanced manufacturing processes and surgeon education programs.

Earlier this month, PrinterPrezz partnered with UCSF Surgical Innovations, a medtech incubator/accelerator at UC San Francisco, to bring advanced medical devices to market faster.

Source: PrinterPrezz