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

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.