Lithoz has announced that its quality management system is now certified to ISO 13485 standards, marking a significant milestone in the company‘s commitment to providing high-performance 3D printing solutions for the medical devices and dental sectors.
Securing the ISO 13485 certification – internationally recognised as the gold standard for quality management in medical device manufacturing – marks Lithoz’s next organizational milestone, underlining their focused commitment to meeting the stringent requirements of patient safety, precision and regulatory compliance. This achievement builds on Lithoz‘s existing ISO 9001 certification and enables FDA QSR compliance. That puts the company straight onto the starting blocks to serve the industry‘s growing demand for reliable, production-ready medical and dental applications.
„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 presence of these standards has removed a major hurdle on our technology‘s path of adoption of our technology.”
With recent milestones such as the clinical validation of bioresorbable implants printed with Lithoz technology or the launch of LithaBite alumina material for translucent orthodontic brackets, Lithoz has consistently been doing its part to shape the future of the medical and dental sector. ISO 13485 certification formally recognizes Lithoz‘s established position in regulated markets, ensuring that its LCM (Lithography-based Ceramic Manufacturing) technology meets the high standards required by medical device manufacturers.
Dominic Weiss, MD of the Vienna Business Agency, a long-time supporter of Lithoz’s way to successful globalization, states: „Lithoz is a beacon of additive manufacturing in Vienna and proof of the city‘s excellent innovation ecosystem. The founders Johannes Homa and Johannes Benedikt established Lithoz 13 years ago as students at the Vienna University of Technology and have built it up to become the global market leader in its field.“ He adds: „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.”
