Faculty Advisor

Belz, Melissa

Faculty Advisor

Hou, Zhikun

Center

DEN / Denmark Project Center

Abstract

Recent concern has arisen over multi-national medical device manufacturers using European patients as metaphorical guinea pigs for testing their devices before seeking approval in stricter regulatory environments. We worked with the Danish Consumer Council to recommend changes to European Union medical device regulation that should help improve patient safety without stifling innovation. We gathered public opinion regarding medical device safety through a survey, and conducted in-depth interviews with key stakeholders. Our end result is a set of proposed reforms to the current EU regulations, including increasing transparency and requiring more clinical trials. Our sponsor will use these recommendations in policy discussion to influence legislation that will increase patient safety.

Publisher

Worcester Polytechnic Institute

Date Accepted

May 2015

Project Type

Interactive Qualifying Project

Accessibility

Unrestricted

Advisor Department

Interdisciplinary Programs

Advisor Department

Mechanical Engineering

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