A.Hopf Kunststoff Logo
We make Healthcare for you.

Quality as competitive advantage

The creation of precision components with high quality is a precondition of the satisfaction of our customers. The manufacturing of quality products is our own standard. This competitive advantage can only be ensured by synchronized quality management system of the individual processes. A. Hopf GmbH is certified according to EN ISO 13485:2012 for the production of medical devices. Especially in the medical field the unrestricted traceability of the products along with the process chain up to the raw material and batch is prerequisite.

Besides the processing and assembly in clean rooms also regular and short-interval in-process controls as well as the labelling of bag numbers ensure additional traceability and process security. The manufacturing of medical devices in clean-rooms class 8 and the clean room controlling with internal measurements and external partners as well as the measuring of the microbiological count by accredited laboratories are part of the regular certification.

Zertifiziert nach
EN ISO 13485:2016