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Coordinating Research and Evidence for Medical Devices

Deliverables

Project Website

Create and maintain a project website coremdeu that will be regularly updated A mission statement will be highlighted in the homepage The web site will offer general information in English about the project its partners and H2020 Programme It will inform about events and activities of the project as well as other relevant news on project topics It will be used for dissemination towards stakeholders and the public Through it open consultations on draft recommendation from the consortium will also be conducted A search box will be an integral part of the site search functionality of the project website Google Analytics will be used to monitor the traffic of the website

Scientific report on statistical methods for medical device trials

Expert recommendations on methods for evaluating clinical trials and studies of highrisk medical devices

Dissemination & Communication Plan

Definition of COREMD dissemination and communication activities providing detailed information on brand recognition target groups media synergies

Report on dissemination and networking

A detailed report describing all the WP activities implemented at Month 18 such as organising meetings conferences and webinars participation in external events and congresses publishing articles conducting surveys and public consultations etc

Project handbook

This document presents the Project coordination aspects and the Project supporting procedures More specifically it describes the knowledge base which consists of procedures tools and information needed to manage and support the Projects activities Finally it contains three sections devoted to Quality Plan to the Risk Management Plan and to Ethical Issues

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Publications

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

Author(s): Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P
Published in: EFORT Open Reviews, Volume/Issue: Volume 6: Issue 10, 2021, Page(s) 839–849
Publisher: EFORT
DOI: 10.1302/2058-5241.6.210081

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).

Author(s): A G Fraser; R G H H Nelissen; P Kjærsgaard-Andersen; P Szymański; T Melvin; P Piscoi; Alan Fraser; Piotr Szymański; Chris P Gale; Aldo P. Maggioni; Elisabetta Zanon; Christina Dimopoulou; Cinzia Ceccarelli; Polyxeni Vairami; Anett Ruszanov; Per Kjærsgaard-Andersen; Rob Nelissen; Adrian Ott; Elizabeth Macintyre; Loredana Simulescu; Marieke Meijer; Berthold Koletzko; Sarah Wieczorek; Adamos Hadj
Published in: European Heart Journal - Quality of Care and Clinical Outcomes, Vol. 8 , no. 3 , pp. 249–258, 2021, ISSN 2058-1742
Publisher: Oxford University Press on behalf of the European Society of Cardiology
DOI: 10.1093/ehjqcco/qcab059