Quality begins at the very first stage of the workflow. During the introduction phase, we define what the product needs to do, under which conditions and within which tolerances.
This is precisely where our early involvement as a partner adds value. This allows us to identify at an early stage where design choices may later affect manufacturability, tooling and process stability.
During the applied engineering phase, a design is often already in place. The question then shifts from “What does it need to do?” to “What does this require from the material, mold, and process?”
This is where the full scope of the challenge is defined. Not from the perspective of any one discipline, but through the interaction between design, process, and production. The result is a proposal that brings together design, material, tooling, process setup, and validation requirements in a well-supported business case.
Not every issue is immediately visible in the design. Many factors only become visible once material, geometry, and process come together.
Using DFM (Design for Manufacturing), DFA (Design for Assembly) , and Moldflow, we make that behavior visible. This provides insight into filling behavior, tolerances, and mold construction, and allows us to assess whether the design intent can be successfully translated into practice.
Within the workflow, there are points at which the design and key assumptions are finalized. The design freeze and data freeze mark the point at which the basis for the next phase is defined.
From there, the focus shifts to tooling, automation, and process setup. This ensures a controlled transition from design to implementation.
During the industrialization phase, it becomes clear how everything comes together. During the realization phase, the design, material selection, tooling, and process settings are turned into a robust process and a finished product that performs as intended.
Validation then confirms that the process performs as intended within the specified parameters. This provides the basis for controlled release and the transition to reliable serial production.
For medical projects, documented evidence is a standard part of the release process. That is why, when required, we provide a COC (Certificate of Conformity) or, where applicable, a COA (Certificate of Analysis).
With a COC, we confirm that the delivered product solution has been produced according to specification. A COA goes one step further: in addition to that confirmation, it also includes the underlying analysis results and measured values. These documents therefore formally complete a process that has already been set up in a controlled and validated manner.
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