From Prototpying to Serial Production
We prefer to accompany you from the very beginning of your development process. From the individual silicone component to the finished assembly - but always with the right focus on the overall solution.
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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