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Gilbert Regan, F. McCaffery, Kevin McDaid, Derek Flood (2013)
Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment modelComput. Stand. Interfaces, 36
- Publisher
- de Gruyter
- Copyright
- Copyright © 2015 by the
- ISSN
- 2364-5504
- eISSN
- 2364-5504
- DOI
- 10.1515/cdbme-2015-0129
- Publisher site
- See Article on Publisher Site
Abstract
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.
Journal
Current Directions in Biomedical Engineering – de Gruyter
Published: Sep 1, 2015