The project group selected three of these approaches and proceeded to develop them into functional models. Development procedures and documentation complied with European and US regulations (EMEA and FDA) from the outset. In a verification process on the functional models, the team zeroed in on the optimum design.
This design was integrated in the housing as part of product implementation. The customer then approved the injector and its design based on samples created in rapid prototyping procedures.
After the design was optimised, the product was ready for series production. Zühlke provided competent assistance with the validation and regulatory approval of the product.