An implant must do more than meet technical requirements. It must work seamlessly in practice. That is why bespoke design, a precise fit and uncompromising quality are not aspirations for us, but standard. Our engineering and production process is built to deliver that standard consistently, giving you complete confidence in the final result.
Every design is tailored to your specific case, workflow and clinical requirements. As an extension of your team, we turn your objectives into a solution that performs reliably in practice.
We think ahead with you and consider the realities of the operating theatre at every stage. Combining your clinical input with our technical expertise and experience, we develop a design that is right down to the finest detail. You review and approve the design, so you can proceed with confidence.
Our production process is centred on maximum precision — in other words, the perfect fit. Using advanced techniques such as 3D printing and 5-axis milling, we create complex shapes and fine details with exceptional accuracy. The result is an implant that matches the patient-specific anatomy exactly.
Quality is safeguarded at every stage. We work in line with applicable guidelines and standards, and continuously monitor our processes in accordance with the four-eyes principle. This gives you the assurance of a reliable, fully validated product.
The final design is always reviewed and approved by the operating surgeon. We only begin production once digital approval has been received.
Quality checks are essential to meet European and local regulations, as well as our own internal quality standards. They help ensure that only products of the highest standard leave our organisation, and that every patient receives a fully validated product that can be implanted safely and reliably.
Our implants are designed, produced, cleaned, packaged, sterilised and shipped entirely in the Netherlands.
We use advanced production techniques, including:
Yes. Every implant is assigned a unique LOT number (starting with XM), allowing us to trace all relevant information linked to the specific case.
For each case, you receive the following documentation:
By working with validated processes that meet the requirements of ISO 13485.
Yes. All our production processes are fully validated and comply with the applicable guidelines.
