Compiling a Medical Device File and a Proposal for an International Standard for Rehabilitation Robots

Römer, GertWillem R.B.E. and Stuyt, Harry J.A. (2007) Compiling a Medical Device File and a Proposal for an International Standard for Rehabilitation Robots. In: IEEE 10th International Conference on Rehabilitation Robotics, ICORR 2007, 13-15 June 2007, Noordwijk, the Netherlands.

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Abstract:	Medical devices produced by manufacturers are subject to regulatory review by authorities. Usually, medical devices are developed at universities and other research institutes. This implies that regulatory activities are to be carried out by the designer at these organizations also. And as early as in the research and design phase of the device. Failing to take into account regulatory requirements in the device phase, has shown to be impeding marketing of new devices. This paper presents guidelines on regulations for the designer. Further, the safety of a medical device can be proven by its compliance with recognized standards. Unfortunately, no standard for Rehabilitation Robots exists. This paper proposes the content of such a standard and invites scientists to contribute to it.
Item Type:	Conference or Workshop Item
Copyright:	© 2007 IEEE
Faculty:	Engineering Technology (CTW)
Research Group:	Mechanical Automation and Mechatronics
Link to this item:	http://purl.utwente.nl/publications/76813
Official URL:	http://dx.doi.org/10.1109/ICORR.2007.4428471
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