Quality processes

High reproducibility in manufacturing processes is vital to achieving quality, and ISO 9001/2008 and ISO EN 13485/2003 certification for medical devices guides us in the definition of our manufacturing and validation processes.

In the area of medical devices we offer you validation of the entire process chain, from design qualification (DQ) to performance qualification (PQ) in accordance with ISO EN 13485.

We work together with you to define component-specific validation processes, and integrate them into the overall manufacturing process.