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Lithoz’s quality management system is now certified to ISO 13485 standards. The company provides high-performance 3D printing solutions for the medical device and dental sectors. This achievement builds on Lithoz‘s existing ISO 9001 certification and enables FDA QSR compliance.
Other recent milestones include the clinical validation of bioresorbable implants printed with Lithoz technology.
“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.”
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.
Source: Lithoz
