risk management for medical devices in research projects

risk management for medical devices in research projects

;Sauter Christian;Heinloth Marion;Tobola Andreas;Pensky Nadine;Weigand Christian
materials science and engineering c 2015 Vol. 1 pp. 543-546
187
christian2015currentrisk

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.

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