Lithoz, a ceramic 3D printing company headquartered in Vienna, has secured ISO 13485 certification for its quality management system, aligning its operations with international standards for medical device manufacturing. The certification, regarded as the benchmark for regulatory compliance in healthcare production, enables Lithoz to meet FDA Quality System Regulation (QSR) requirements and expands its role in supplying 3D printed components for medical and dental applications.
Founded in 2011 by researchers at the Vienna University of Technology, Lithoz has developed lithography-based ceramic manufacturing (LCM) systems for producing high-performance parts with fine resolution. The new certification builds on its ISO 9001:2015 status and removes a key regulatory barrier for clients developing clinical-grade devices. “This certification reinforces our leading role as a trusted technology partner to medical innovators,” said Dr. Daniel Bomze, Director of Medical Solutions. “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.”
A technician prepares materials in a cleanroom at Lithoz. Photo via Lithoz.
Recent developments include the clinical validation of bioresorbable implants produced using Lithoz systems, along with the commercial launch of LithaBite, a translucent alumina-based material engineered for orthodontic brackets. These milestones demonstrate how LCM technology is being adapted to meet the strict tolerances and material requirements of healthcare use cases. ISO 13485 certification provides formal recognition that Lithoz’s manufacturing process and internal documentation conform to the expectations of global regulatory bodies.
Company co-founders Johannes Homa and Johannes Benedikt initially established the firm as a university spinout. Today, the company employs over 120 staff across four international locations and exports nearly 100% of its output. “Lithoz is a beacon of additive manufacturing in Vienna and proof of the city’s excellent innovation ecosystem,” said Dominic Weiss, Managing Director of the Vienna Business Agency. “The founders 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.”
With this certification, Lithoz advances its capacity to support clients working on implantable devices, dental restorations, and other applications requiring strict quality assurance protocols. The update also positions the company to accelerate clinical partnerships under regulated frameworks in both European and U.S. markets.
Lithoz logo. Image via Lithoz.
Additive manufacturing aligns with sector-specific certification frameworks
Manufacturing on Demand
In early 2025, Titomic, an Australian company focused on cold spray-based additive manufacturing, signed a strategic collaboration agreement with DNV, a global assurance body. The partnership aims to certify Titomic’s Kinetic Fusion process for use in the maritime and offshore energy sectors, targeting qualification under the NORSOK M-501 standard. That standard, developed by Norway’s petroleum industry, defines performance requirements for surface coatings on offshore structures. Titomic also plans to engage with additional classification societies such as ABS and Bureau Veritas to broaden acceptance of its process in field-deployed repair, restoration, and corrosion protection scenarios.
A similar push for sector-specific validation is taking place in Spain. In April 2025, Sicnova inaugurated CEDAEC, the country’s first dedicated 3D technology center for military and defense sector certification. Located within Novaindef’s facilities, the initiative operates in collaboration with Spain’s Ministry of Defense to produce, inspect, and certify mission-critical components. The facility is equipped for metal and polymer 3D printing, reverse engineering, and high-precision tomography for internal part inspection. According to Sicnova CEO Ángel Llavero, the integration of additive manufacturing with rigorous quality control frameworks is intended to address obsolescence, streamline supply chains, and increase the resilience of defense logistics systems.
Spanish distributor Sicnova secures exclusive UltiMaker distribution across the Iberian Peninsula. Photo via Sicnova.
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Author: Anyer Tenorio Lara
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