| Property | Value |
|---|
|
?:abstract
|
-
Objectives: To promote medical device EU regulatory understanding in the biomedical research community and encourage greater levels of clinical engagement to further medical device research innovation, translation and effective clinical trials. Methods: An interdisciplinary, iterative, needs-based design approach was used to develop medical device regulatory training, information and clinical expertise resources. Results: A multimedia based self-paced e-Learning course focusing on the \'Fundamentals of Medical Device Design and Regulation\' was produced in tandem with an interactive online web portal: Medtech Translate. Conclusions: Health research translation relies on both clinical input and regulation to drive progress and to ensure quality and safety standards from concept development to clinical investigation. A lack of regulatory awareness and access to clinical expertise has the potential to significantly impact on health research translation and ambition for market. Our interdisciplinary academic-regulator-clinical-industry led approach meets the need for a coordinated stakeholder response to support innovation and promote growth in the medical technology sector.
|
|
is
?:annotates
of
|
|
|
?:creator
|
|
|
?:license
|
|
|
?:publication_isRelatedTo_Disease
|
|
|
?:source
|
|
|
?:title
|
-
A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement
|
|
?:type
|
|
|
?:who_covidence_id
|
|
|
?:year
|
|
![[This page as RDF]](https://research.tib.eu/covid-19/static/rdf-icon.gif){kind=icon}