Lithoz
Lithoz has seen its quality management system certified to ISO 13485 standard, better establishing the company’s credentials within the medical and dental sectors.
The company believes it to be its latest organisational milestone and underlines its ‘focused commitment’ on meeting the stringent requirements of patient safety, precision and regulatory compliance within the healthcare industries. Lithoz has already obtained ISO 9001 certification and enables FDA QSR compliance.
Having already enabled such medical developments as the clinical validation of bioresorbable implants and the LithaBite alumina material for translucent orthodontic brackets, as well as the first implanted jaw implant produced with ceramic 3D printing, Lithoz believes it will now be able to better facilitate next-generation 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.”
“Lithoz is a beacon of additive manufacturing in Vienna and proof of the city’s excellent innovation ecosystem,” added Dominic Weiss, MD of the Vienna Business Agency. “The founders Johannes Hoima 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 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.”
