Production

From prototype to full-scale production

As an experienced development and production service provider, we know what really matters when it comes to the launch, production, storage and shipping of medical devices in all risk classes. We’re happy to support you with comprehensive supply chain management as well as scalable manufacturing and logistics solutions. For this we work with certified partners and suppliers, and flexibly manufacture the volume you require.

As a manufacturer, we know all about the approval requirements for medical devices and we will ensure that your solution complies with all relevant standards.

Pilot run & production launch

After creating the prototype, we transfer your product into the pilot run. We dovetail development and the transition to production at an early stage, thereby ensuring that you always have full cost control and remain competitive in the global market in the long term.

Module assembly

We take over the job of wiring, cabling and assembly of electronic modules, circuits and complete devices for you. At our company headquarters in Erlangen, we concentrate on complex systems with medium volume, whereas we have high quantities (> 3000 per year) produced in Henstedt-Ulzburg.

Production and testing equipment

During production, our technicians employ a wide range of testing equipment and, if required, they will also manufacture testing equipment to your specifications, which enables specific quality testing of your module.

Quality management

We’ve already had products approved according to 510 (k) for the American market numerous times. As a European Authorized Representative (E.A.R.), we represent you within the EU and ensure compliance with the European directives.

Quality Certificates: DIN EN ISO 13485   MDD, Appendix II