Lithoz achieves ISO 13485 certification for medical device manufacturing, expanding ceramic AM capabilities
Lithoz, based in Vienna, Austria, has announced that its quality management system is now certified to ISO 13485 standards. This is said to mark a significant milestone in the company’s commitment to providing high-performance Additive Manufacturing solutions for the medical devices and dental sectors.
The ISO 13485 certification is internationally recognised as the gold standard for quality management in medical device manufacturing. This achievement builds on Lithoz’s existing ISO 9001 certification and enables compliance with the FDA’s QSR, positioning the company to meet the industry’s growing demand for reliable, production-ready medical and dental applications.
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“This certification reinforces our leading role as a trusted technology partner to medical innovators,” said Dr Daniel Bom- ze, 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.”
ISO 13485 certification formally recognises Lithoz’s established position in regulated markets, ensuring that its Lithography-based Ceramic Manufacturing (LCM) technology meets the high standards required by medical device manufacturers.
Dominic Weiss, MD of the Vienna Business Agency stated, “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.”
“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,” Weiss added.
