Lithoz, a high-performance ceramic supplies and 3D printing expertise firm, has licensed its high quality administration system to ISO 13485 requirements, marking a big milestone in its dedication to offering high-performance 3D printing options for the medical gadgets and dental sectors.
Securing the ISO 13485 certification – internationally acknowledged because the gold commonplace for high quality administration in medical machine manufacturing – marks Lithoz’s subsequent organizational milestone, underlining their targeted dedication to assembly the stringent necessities of affected person security, precision, and regulatory compliance. This achievement builds on Lithoz‘s current ISO 9001 certification and permits FDA QSR compliance.
“This certification reinforces our main function as a trusted expertise associate to medical innovators,“ mentioned Dr. Daniel Bomze, Director of Medical Options at Lithoz. “It permits us to supply a dependable and low-risk entry level into LCM ceramic 3D printing to the numerous pioneers within the healthcare and dental business, accelerating the event of next-generation medical gadgets, purposes, and supplies from preliminary prototype to serial manufacturing. The presence of those requirements has eliminated a significant hurdle on our expertise‘s path of adoption of our expertise.”
With latest milestones such because the medical validation of bioresorbable implants printed with Lithoz expertise, or the launch of LithaBite alumina materials for translucent orthodontic brackets, Lithoz has been constantly shaping the way forward for the medical and dental sector. ISO 13485 certification formally acknowledges Lithoz‘s established place in regulated markets, guaranteeing that its LCM (Lithography-based Ceramic Manufacturing) expertise meets the excessive requirements required by medical machine producers.
“Lithoz is a beacon of additive manufacturing in Vienna and proof of the town‘s wonderful innovation ecosystem. The founders, Johannes Homa and Johannes Benedikt, established Lithoz 13 years in the past as college students on the Vienna College of Know-how and have constructed it as much as turn into the worldwide market chief in its discipline,” mentioned Dominic Weiss, MD of the Vienna Enterprise Company, a long-time supporter of Lithoz. “We congratulate Lithoz on this achievement. It opens the door to essentially change the medical sector – and to additional strengthen Vienna as a hub for all times sciences in Europe.”
