Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices-Reference-Cited by-同舟云学术

Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices

Published:2022-11 Issue:11 Volume:26 Page:5282-5286
ISSN:2168-2194
Container-title:IEEE Journal of Biomedical and Health Informatics
language:
Short-container-title:IEEE J. Biomed. Health Inform.

Author:

Pappalardo Francesco¹^ORCID,Wilkinson John²,Busquet Francois³,Bril Antoine⁴,Palmer Mark⁵,Walker Barry⁶,Curreli Cristina⁷^ORCID,Russo Giulia¹^ORCID,Marchal Thierry⁸,Toschi Elena⁹^ORCID,Alessandrello Rossana¹⁰^ORCID,Costignola Vincenzo¹¹,Klingmann Ingrid¹²,Contin Martina¹³,Staumont Bernard¹⁴^ORCID,Woiczinski Matthias¹⁵,Kaddick Christian¹⁶^ORCID,Salvatore Valentina Di¹,Aldieri Alessandra⁷^ORCID,Geris Liesbet¹⁴^ORCID,Viceconti Marco⁷^ORCID

Affiliation:

1. Department of Drug and Health Sciences, University of Catania, Catania, Italy

2. GMDN Agency, Oxford, U.K.

3. Altertox Academy, Brussels, Belgium

4. European Federation of Pharmaceutical Industries and Associations, Ixelles, Belgium

5. EU Research & Innovation Partnership Policies of MedTech Europe, Brussels, Belgium

6. TuBerculosis Vaccine Initiative, Lelystad, The Netherlands

7. Department of Industrial Engineering, Alma Mater Studiorum, University of Bologna, Bologna, Italy

8. Ansys Inc. (USA) and Avicenna Alliance-Association for Predictive Medicine, Brussels, Belgium

9. Istituto Superiore di Sanità, Rome, Italy

10. Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain

11. European Medical Association, Brussels, Belgium

12. European Forum for Good Clinical Practice, Brussels, Belgium

13. VPH Institute, Brussels, Belgium

14. GIGA In Silico Medicine, University of Liège, Liège, Belgium

15. Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich, University Hospital LMU Munich, Munich, Germany

16. EndoLab Mechanical Engineering GmbH, Riedering, Germany

Funder

European Commission through the H2020 Project

In Silico World: Lowering barriers to ubiquitous adoption of In Silico Trials

STriTuVaD: In Silico Trial for Tuberculosis Vaccine Development

Publisher

Institute of Electrical and Electronics Engineers (IEEE)

Subject

Health Information Management,Electrical and Electronic Engineering,Computer Science Applications,Health Informatics

Link

http://xplorestaging.ieee.org/ielx7/6221020/9945616/09855387.pdf?arnumber=9855387

Reference28 articles.

1. Accelerating COVID-19 Research Using Molecular Dynamics Simulation

2. Modeling studies in medical device submissions;morrison,2022

3. Assessing credibility of computational modeling through verification and validation: Application to medical devices,2022

4. In silico assessment of biomedical products: The conundrum of rare but not so rare events in two case studies

5. An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials

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