Certified Quality: 1to1 manufactures plastic parts for medical technology according to EN ISO 13485

1-to-1 manufactures series components in cleanroom conditions for medical technology companies according to EN ISO 13485. (Photo: Darko Todorovic)

1-to-1, the EN ISO 13485 certification for the production of medical devices is achieved. In the picture: Thomas Kohler (CEO), Philipp Schelling (Production Management Vacuum Casting & 3D Printing), Bernd Patscheider (Production Management Toolmaking & Injection Molding), and Mert Ünal (Quality Management Director). (Photo: Darko Todorovic)

Thomas Kohler is CEO of 1zu1. (Photo: Darko Todorovic)

1to1 realized for medical technology functional series components and prototypes made of plastic. The Dornbirn-based high-tech company has just successfully completed the international certification EN ISO 13485. In the first half of 2025, the specialist in 3D printing and injection molding doubled the unit numbers for series projects and recorded a 10 percent increase in sales.

Safety, functionality, and transparency: 1to1 fulfills all criteria for approval-compliant products as a manufacturing partner for medical technology. The high-tech company based in Dornbirn is now certified according to EN ISO 13485. With this organizational milestone, 1to1 emphasizes its position as a complete provider for small, precise plastic components in strictly regulated markets. The specialist in 3D printing, injection, and vacuum casting covers the entire value chain—from functional prototypes to precise series production—a benefit in approval procedures.

“Every day counts during the market launch of medical innovations. At the same time, safety is central for all components. We create quickly and reliably customized solutions that meet the highest requirements. This saves our customers a lot of time,” says CEO Thomas Kohler. The quality management system for medical technology products complements the existing ISO 9001 system since 2015. Thanks to efficient space and climate technology, constant conditions prevail in the production areas. Depending on the need, 1to1 also manufactures in cleanrooms. Transparent processes and detailed documentation ensure quality and minimize risks.

Strong first half of the year

Doubling of series unit numbers and a 10 percent increase in sales compared to the previous year are positive signals for 1to1’s future. This continues the upward trend from the second half of 2024 seamlessly. “The industry is investing more again in research and development. At the same time, it is very cost-sensitive. We support with a variety of technologies, automation, and service. Now, our strategic measures for more efficiency and flexibility are paying off,” reports Kohler.

Growth is particularly strong in series business—regardless of the industry. Both in 3D printing and injection molding, 1to1 was able to double unit numbers. “Awareness of the added value of our offerings is continuously increasing. What was just a vision a few years ago is now a reality: we produce immediately usable prototypes and hundreds of thousands of series components within a few weeks—including quality assurance,” says Kohler. The recovery calls for personnel expansion. Currently, 1to1 is actively seeking business developers for a stronger presence in the European market as well as new employees in shipping, purchasing, sales support, and warehousing.