Dr. Fritz Faulhaber GmbH & Co. KG, a company within the globally active FAULHABER GROUP, has been awarded certification in accordance with DIN EN ISO 13485:2007 by TÜV Süd Product Service. This confirms FAULHABER's position as the leading provider of drive systems, precision systems and microsystems, particularly in the field of medical engineering.

The certification is the result of the consistent further development of the quality management system, with a view to meeting the demands placed on manufacturers of medical devices. The company is already successfully certified in accordance with ISO 9001 and 14001, and has carried out extensive work over the past few years to improve its internal processes and procedures.

"Optimal cooperation and the tight coordination of all those involved have made it possible to receive this certificate in record time, and at the first attempt," says Joerg Rittker, Quality Manager at FAULHABER. The management also views the result as extremely positive: "This is a great success, particularly when you consider that the legal regulations for devices in medical engineering require considerably more documentation and specifications than ISO 9001, and the requirements are also much greater," confirms Dr. Thomas Bertolini, Managing Director of FAULHABER.

As a manufacturer of high-precision Microsystems, FAULHABER has for many years supplied a large number of international customers, particularly in the field of medical and laboratory equipment. The development and production of customer-specific drive solutions plays an important role here. These range from special components designed specifically for the customer application, to system partnerships with jointly coordinated development, design and automated production of complete mechatronical systems.

The ISO 13485 certification represents an important milestone for "FAULHABER Custom Solutions". It allows FAULHABER to guarantee its customers that all processes throughout the entire procedure of value creation are controlled and fully documented in detail, thus meeting FAULHABER's strict quality requirements. This provides a solid platform for future medical engineering projects, and guarantees reliability and product safety for customers around the world.

Courtesy of Faulhaber Group