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Dictionary:
Completed

Support measures for clinical studies on medical devices

The purpose was to evaluate the need for support and training from regional nodes for researchers carrying out clinical studies with medical devices.

Background

The regulatory framework for studies of medical technology products has been updated over the last few years, which has resulted in there being few persons who have a complete overview. The regulatory framework also differs for studies of medical technology products and studies of pharmaceuticals.

Implementation

The project carried out a needs analysis with interviews with researchers within academia and healthcare and other supporting functions available in the regions in order to find out what their needs are in terms of support from the nodes. The project also carried out a contemporary environment analysis by summarising published reports and articles in order to further identify needs and any proposed solutions. The material collected was analysed in order to make proposals for measures, thereby removing obstacles to the implementation of clinical studies of medical technology products. The proposals was sent out for comments to all regional nodes and other stakeholders in the project.

Goals

The results of the proposals from the nodes and the other stakeholders was presented in a report. The report documented the services that was required at the nodes. It was also described how the proposed services should be developed at the regional nodes, and how collaboration should take place. The project also described how this support could be provided to academia, industry and healthcare.

Time plan

The project started in Q2 2016 and was expected to be completed by the beginning of Q3 2017.