risk management for medical devices in research projects

Clicks: 194
ID: 252747
2015
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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.
Reference Key
christian2015currentrisk Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Sauter Christian;Heinloth Marion;Tobola Andreas;Pensky Nadine;Weigand Christian
Journal materials science and engineering c
Year 2015
DOI
10.1515/cdbme-2015-0129
URL
http://www.degruyter.com/view/j/cdbme.2015.1.issue-1/cdbme-2015-0129/cdbme-2015-0129.xml?format=INT
Keywords
risk management research

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