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Biomedical engineering is subject to the standard DIN EN ISO 13485:2016. This norm lays out the requirements for quality management systems covering medical device design, development, manufacture, installation and maintenance. Machinery used in medical device manufacturing must offer a high degree of precision and reliability. These requirements became even more demanding with the European Medical Devices Regulation (MDR). Medical device manufacturers must also pay attention to quality management for outsourced processes.

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