MAZeT Prepares Certification of Its Process Organization according to Medical Standard 13485

Development and Production of Medical Electronics Are Increasingly Becoming a Focal Point
MAZeT Prepares Certification of Its Process Organization according to Medical Standard 13485

The development and production of electronics for medical equipment is becoming increasingly important in the market orientation of MAZeT GmbH – development and production service provider for embedded computing solutions and optoelectronics located in the city of Jena – and, consequently, in its sales, too. In order to meet customer demands, MAZeT is regularly and increasingly required to depict partial processes conforming to the DIN EN ISO 13485 standard in projects for developing and producing modules or ASICs for medical equipment. Uwe Berghäuser, Sales Manager at MAZeT GmbH, explains: „Our customers in medical electronics expect MAZeT to support them in complying with legal provisions and standards and that we also assume documented responsibility for the services provided.“

The decision taken as a result of the past development of business to orient part of MAZeT’s business on the market for medical electronics in the long term entails the necessity of process certification according to DIN EN ISO 13485. There are currently activities for checking the on-going process and the introduction of risk management according to DIN EN ISO 14971. The goal of the activities is to obtain the DIN ISO 13485 in 2012 certificate.

About MAZeT

MAZeT GmbH is a leading European development and production service provider. The company was founded in 1992 and is based in Jena, Germany. MAZeT GmbH develops, produces and supplies customized electronic modules, software and ASICs and sells proprietary products under the brand JENCOLOR worldwide. Thanks to its wide-ranging technology offer and application know-how, MAZeT GmbH is a reliable and tried-and-tested service partner for customized solutions in the areas of industrial electronics and optic sensor technology. Its development competence and components for special applications are used in the complete area of industrial measuring technology, control and automation technology as well as medical engineering, among others.

MAZeT GmbH
Diane Damer
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