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Risk management for medical devices in research projects

Risikomanagement in Forschungsprojekten
 
: Sauter, Christian; Heinloth, Marion; Pensky, Nadine; Tobola, Andreas; Weigand, Christian

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Current directions in biomedical engineering 1 (2015), Nr.1, S.543-546
ISSN: 2364-5504
Englisch
Zeitschriftenaufsatz
Fraunhofer IIS ()
Risiko-Analyse; Medizintechnik; ISO 14971 Risikomanagement b. Medizinprodukten

Abstract
In applied research for medical devices exists a conflict between effective research and regulations. While researchers need sufficient freedom the regulations require a complex technical documentation for a medical device. One relevant aspect of the regulations is risk management which takes time and therefore is ignored in many research projects. With adoptions to the standard the effort can be reduced: Identifying of risks can be focused on critical risks, measures can be categorised and only some categories need to be implemented. Research teams using this method can provide results which can be transferred into commercial products easier, cheaper and faster.

: http://publica.fraunhofer.de/dokumente/N-375789.html