Regulatory Competences

Business Unit »Systems and Applications«

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The Fraunhofer Institute for Electronic Nano Systems ENAS received the DIN EN ISO 9001:2015 certification by DEKRA in December 2019. This certification is the basis for technology as well as product development ordered by our customers working in different branches.

The field of medical technology developments is highly regulated and the acceptance thresholds, e.g. clinical application tests and the corresponding CE markings of technical products and services according to the medical technology standard, are naturally very high.

Based on the developed application proposals, we therefore accompany our industrial partners in the development-accompanying documentation in order to enable agile product development with targeted compliance with the requirement tracings and medical technology regulations. To this end, we draw on expert know-how in all relevant medical technology standards.