R & D
Research and development form the backbone of our organization. Our experienced engineers, with divers backgrounds in fields such as material science and chemistry, are able to turn revolutionary ideas into high-class materials. Thanks to our extensive experience, we have expertise in several different production processes. This enables us to produce materials with characteristics tailored to the application.
As a university spin-off, we have always maintained a strong relationship with world-class academic institutions for the development of new products. We are currently involved in various academic research projects to develop the next generation of calcium phosphates.
Co-Development & Upscaling
As a contract manufacturer, we are experts in developing products on request. Our decades of experience enable us to provide expert advice on the composition of new products. Furthermore, we can make the transition from an engineering product to upscaled production. With several different production methods available, we are able to upscale all of the processes into full production.
Regulatory Approval of rapid TTM
Our ISO 13485-compliant quality management system ensures that our design, development, validation and change control procedures facilitate smooth regulatory approval. We are well-known with regulatory bodies, and understand what is needed for 510k clearance and FDA, CE or CFDA approval. For many materials, our FDA Master Access File or our Design History Files will be conducive for a rapid time-to-market for your products.
As a complementary service, we offer customer-specific packaging: from clean transport packaging, to final clean room packaging. With our class-7 cleanrooms, bioburden measurements and excellently trained staff, we have everything in place to provide our customers with full-service packaging services.
We can support all of the steps in the packaging process, including cleaning, packaging and labeling. Whether it’s packaging of implants or a double- blister packaging for granules you are looking for, we can safeguard the complete packaging process. Thanks to our extensive experience, we can help you choose the right packaging for the best product handling. We can also support you with packaging validation.
HA Plasma-Spray Coating Services
With more than three decades of experience as a HA coating service supplier, we know what is important when it comes to HA coatings. We offer flawless coatings, excellent service and short lead-times.
Over the years, we have been involved in providing HA coatings for patient specific 3D-printed implants, as well as large quantities of dental, orthopedic and other implants. We are specialized in the most challenging and demanding implants. For example, we are able to coat minuscule ossicular prostheses (1.5mm) and odd-shaped custom implants.
Our coating experts are available to assess how we can provide added value by supplying the best HA Coating and Coating Powders on the market, tailored to your needs.
As the industry pioneers in HA Coating, we can help you improve your coating capabilities. We have experience with the most challenging customized implants as well as with high-quantity generic implants. As a result, we are delighted to be the partner of choice for leading players in the industry.
Contact us to discuss how we can support you with our activities.