A new quality seal for medical technology.
Following the footsteps of development center in Nuremberg and the production site in Monheim, the plant in Chihuahua, Mexico, has now gained an additional quality certification for medical technology. With the DIN EN ISO 13485:2012 certification, audited by TÜV Süd, Bühler Motor focuses on special safety requirements for medical devices.
In accordance with the guidelines, not only production but also the entire supply chain from procurement through components storage and plant maintenance to provision and delivery to customers, comes under intense scrutiny.
Certification requires total compliance throughout all of the process steps. Special attention is paid to systematic and complete documentation and risk management. This is not just about minimizing risk but concerns guaranteeing optimal traceability of batches of products and parts in the event of problems.
“As a family business and an SME, we find it easier to be aware of the special responsibility each of us bears in the development and production of healthcare products. Buehler Motor de Mexico Plant Manager Cristina Sanchez: “Ultimately, it is about making sure that all risks for users, that is patients, are excluded, if at all possible.”
Theo Schwarz, Director Product Segment Healthcare Solutions, Bühler Motor GmbH: “We have taken a further important step on the path to becoming an even more attractive partner for our clients in medical technology. We are underpinning our expertise in the medical devices field and we are fit to take on future projects from large medical device manufacturers and pharmaceutical concerns worldwide.”