Bühler Motor: Mexico plant certified to DIN EN ISO 13485:2012 standard
Proud of the certification (from left to right): K. Müller, A. Estrada, R. Schwab, E. Ruelas, M. Nevárez, C. Sanchez, P. Muhr
Nuremberg, 30th August 2017 – 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.”
About Bühler Motor
Bühler Motor stands for demanding, custom-made, and reliable mechatronic drive solutions with DC/BLDC small motors and gear motors and pumps.
More than one of out every ten employees at Bühler Motor works in Research and Development. Our in-house sample shop and R&D department, combined with state-of-the-art test labs, enable Bühler to concentrate completely on quick and flexible development of customer specific drive solutions.
1,750 employees worldwide ensure successful development, industrialization and production of mechatronic drive solutions for mid- to high volume applications.
With eleven locations on three continents and highly developed process competencies, Bühler Motor is able to fulfill all customer requirements for short transit times, quality, and on-time delivery at the required volumes.
The company’s strategic markets include the automotive market, the healthcare equipment market, general industrial solutions in the fields of building automation, agriculture, transportation and seat actuation for aviation.
Phone: +49 911 45 04-1129
Fax: +49 911 43 08 69-1129
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