Dornbirn, July 7, 2025 – 1zu1 manufactures functional series components and prototypes made of plastic for medical technology. The Dornbirn-based high-tech company has just successfully completed the international EN ISO 13485 certification process. In the first half of 2025, the specialist for 3D printing and injection molding doubled the number of units in series projects and recorded a 10 percent increase in sales.
Safety, functionality, and transparency: as a manufacturing partner for medical technology, 1zu1 meets all criteria for approval-compliant products. The high-tech company based in Dornbirn is now EN ISO 13485 certified. With this organizational milestone, 1zu1 underscores its position as a full-service provider of small, precise plastic components in strictly regulated markets. The specialist for 3D printing, injection molding, and vacuum casting covers the entire value chain from functional prototypes to precise series production—an advantage in the context of approval procedures.
"When launching medical innovations, every day counts. At the same time, safety is paramount for all components. We create customized solutions quickly and reliably that meet the highest requirements. This saves our customers a lot of time," says CEO Thomas Kohler. Quality management for medical technology products complements the ISO 9001 system that has been in place since 2015. Thanks to efficient room and climate control technology, conditions in the production rooms remain constant. Depending on requirements, 1zu1 also manufactures in clean rooms. Transparent processes and detailed documentation ensure quality and minimize risks.
Strong first half-year
With twice as many series production units and a 10 percent increase in sales compared to the previous year, 1zu1 is optimistic about the future. This continues the upward trend of the second half of 2024. "The industry is once again investing more in research and development. In doing so, it is acting in a very cost-sensitive manner. We support this with technological diversity, automation, and service. Our strategic measures for greater efficiency and flexibility are now paying off," reports Kohler.
Growth in the series production business is particularly strong, regardless of the industry. 1zu1 was able to double its production volumes in both 3D printing and injection molding. "Awareness of the added value of our offering is growing steadily. What was still a vision a few years ago is now reality: we produce ready-to-use prototypes and hundreds of thousands of series components in just a few weeks – including quality certification," says Kohler. The upturn requires additional personnel. 1zu1 is currently looking for business developers to strengthen its presence on the European market, as well as new employees in shipping, purchasing, internal sales, and warehousing.
