Lithoz has received ISO 13485 certification for its quality management system, supporting its ability to deliver ceramic 3D printing solutions for use in the medical and dental sectors.
The ISO 13485 certification is internationally recognised as the benchmark for quality management systems specific to the design and manufacture of medical devices, the company said in a news release.
For Lithoz, it marks a key milestone in expanding its capabilities within highly regulated markets and aligning its processes with the stringent requirements for patient safety, product quality, and regulatory compliance.
“This certification reinforces our leading role as a trusted technology partner to medical innovators,” said Dr Daniel Bomze, Director of Medical Solutions at Lithoz.
“It enables us to provide a reliable and low-risk entry point into LCM ceramic 3D printing to the many pioneers in healthcare and dental industry, accelerating the development of next-generation medical devices, applications and materials from initial prototype to serial production.”
The certification builds on Lithoz’s existing ISO 9001 accreditation and also positions the company for FDA Quality System Regulation (QSR) compliance.
The move is expected to ease the integration of its Lithography-based Ceramic Manufacturing (LCM) technology into clinical workflows and commercial supply chains.
Recent developments at Lithoz include the clinical validation of bioresorbable implants manufactured with its technology and the release of LithaBite, a translucent alumina material for 3D printing of aesthetic orthodontic brackets.
These innovations have highlighted Lithoz’s commitment to shaping the future of healthcare by advancing the capabilities of ceramic additive manufacturing.
Dominic Weiss, Managing Director of the Vienna Business Agency, praised the achievement as a reflection of the city’s strong innovation ecosystem.
“Lithoz is a beacon of additive manufacturing in Vienna and proof of the city‘s excellent innovation ecosystem,” Weiss said.
“We congratulate Lithoz on this achievement—it opens the door to fundamentally change the medical sector and to further strengthen Vienna as a hub for life sciences in Europe.”
Lithoz was established in 2011 by Johannes Homa and Johannes Benedikt during their time at the Vienna University of Technology.
