The Medical Devices Regulations (MDR) in Europe have a major impact on medical devices and software developed in research institutes. A strategic program at the University of Twente supports researchers with practical formats of the Investigational Medical Device Dossier IMDD including risk assessment and ethical approval for clinical studies. The R&D facilities have a QMS in the spirit of ISO 9001 and 13485 to ease the transfer to a commercial partner or spin-off company. A maturity scan helps researchers to determine ‘missing’ parts for successful implementation of a medical device to the market. These practical tools accelerate the successful implementation of medtech innovations to the health market.
Access to the requested content is limited to institutions that have purchased or subscribe to SPIE eBooks.
You are receiving this notice because your organization may not have SPIE eBooks access.*
*Shibboleth/Open Athens users─please
sign in
to access your institution's subscriptions.
To obtain this item, you may purchase the complete book in print or electronic format on
SPIE.org.
INSTITUTIONAL Select your institution to access the SPIE Digital Library.
PERSONAL Sign in with your SPIE account to access your personal subscriptions or to use specific features such as save to my library, sign up for alerts, save searches, etc.