Plastic Parts Medical Technology
Reliable, Reproducible, Ready for Series Production
Plastic parts for medical technology must meet the highest requirements. On the one hand, due to the sensitive areas of application, this sector is subject to numerous national and international standards and regulations in order to guarantee the end user the greatest possible safety and the best protection. On the other hand, this standardization requires high-precision work in order to comply with the standards and meet all safety requirements.
Consulting right from the Start
Whether in toolmaking with injection molding, 3D printing, or vacuum casting, 1zu1scale is able to guarantee these specifications thanks to a wide range of materials and processes. And all this in the shortest possible time. CT measurements with digital archiving are standard practice for us. ISO and clean room certification? Possible at any time at 1zu1scale. In order to best meet all your wishes and needs, we rely on competent advice from our experts. They are happy to assist you. Right from the start.
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Certification according to EN ISO 13485
As a manufacturing partner for plastic parts for medical technology, 1zu1scale meets all criteria for approval-compliant products. The EN ISO 13485 certificate qualifies us to manufacture medical devices and is a visible sign of quality, traceability, and regulatory compliance.
Learn More
Consulting
Consulting right from the Start
Whether in toolmaking with injection molding, 3D printing, or vacuum casting, 1zu1scale is able to guarantee these specifications thanks to a wide range of materials and processes. And all this in the shortest possible time. CT measurements with digital archiving are standard practice for us. ISO and clean room certification? Possible at any time at 1zu1scale. In order to best meet all your wishes and needs, we rely on competent advice from our experts. They are happy to assist you. Right from the start.
Get in Touch
Certification
Certification according to EN ISO 13485
As a manufacturing partner for plastic parts for medical technology, 1zu1scale meets all criteria for approval-compliant products. The EN ISO 13485 certificate qualifies us to manufacture medical devices and is a visible sign of quality, traceability, and regulatory compliance.
Learn More
1zu1scale thinks along with us. Good suggestions, honest, open communication, and face-to-face meetings make it easier for us to implement our ideas and designs. As a developer, this service was a new experience for me. This is exactly how I imagine a solution-oriented manufacturing partner to be.
Felix Schneider,Development Engineer at Qatna Medical GmbH
Additional Questions on this Topic
We combine technological diversity with regulatory certainty. Our processes and material selection are documented, traceable, and audit-ready. We accompany your components from the initial design to delivery ready for series production.
We manufacture high-precision plastic components for medical applications—from components for diagnostic devices to housings and functional parts for medical devices. Quality and safety are always our top priorities.
Our manufacturing is certified according to EN ISO 13485, the international standard for quality management in medical technology. This guarantees the safety, reliability, and regulatory compliance of our products.
We work nationally and internationally with companies in the fields of diagnostics, medical devices, laboratory and research technology – from start-ups to established brand manufacturers.
Our customers benefit from precise, high-quality components, documented processes, certified manufacturing, and the reliable implementation of complex projects—all from a single source.
All manufacturing processes are regularly audited, documented in a standardized manner, and implemented in accordance with EN ISO 13485. This ensures that every component meets the highest quality requirements.