Quality is … achieving perfection and avoiding perfectionism: Our quality management system enables us to produce efficiently and in conformance with standards.
Comply with Standards.
Stringent requirements apply for medical products worldwide – for a good reason. A large number of standards and the demanding directives of the US Food and Drug Administration (FDA) regulate licensing and use. Our prototypes and end products comply with all these standards. This means our implants are used successfully worldwide.
The Strictest Standard.
Fulfilling regulatory standards is the real challenge. But we want more: This is why we implement our customer’s individual requirements directly, e.g. with extensive production-accompanying forms and documentation from our quality management system. This transparency underlines the trust in our quality and performance.
Everything in View.
Everything under Control.
Our quality management system guarantees that all production processes are planned, controlled and monitored smoothly. Hence we can dependably meet all customer quality assurance requirements. Our quality management is maintained and documented according to DIN ISO 13485 and the directive FDA 21 CFR Part 820. This precisely defines all production processes and the flow of information.
ISO 13485 Medical devices
Quality management systems
Download: “ISO-13485” – Certificate as PDF