The development and production of electronics for medical equipment has become increasingly important in the market orientation of MAZeT GmbH. Therefore, 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, MAZeT GmbH, explained: “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.