Certified quality
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.
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1zu1 obtains EN ISO 13485 certification for the production of medical technology products. Pictured: Thomas Kohler (CEO), Philipp Schelling (Production Manager, Vacuum Casting & 3D Printing), Bernd Patscheider (Production Manager, Toolmaking & Injection Molding), and Mert Ünal (Head of Quality Management). -
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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.
Contact datas:
Phone: +43 5572 33 333-0
E-Mail: info@1zu1.eu
Homepage: www.1zu1.eu
