Ceramic 3D printing company Lithoz has received the ISO 13485 certification. This certification confirms that the company’s quality management system meets the standards for the medical devices and dental sectors.
Internationally recognised as the gold standard for quality management in medical device manufacturing, this standard marks the manufacturer’s 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 as it ensures that the company’s LCM (Lithography-based Ceramic Manufacturing) technology meets the high standards required by medical device manufacturers.
“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.”
The announcement follows the recent clinical validation of bioresorbable implants printed with LCM and the release of LithaBite.
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