en
Completed

Support measures for clinical studies on medical devices

The purpose is 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 will carry 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 will also carry out a contemporary environment analysis by summarising published reports and articles in order to further identify needs and any proposed solutions. The material collected will be analysed in order to make proposals for measures, thereby removing obstacles to the implementation of clinical studies of medical technology products. The proposals will be 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 will be presented in a report. The report will document the services that may be required at the nodes. It will also describe how the proposed services shall be developed at the regional nodes, and how collaboration shall take place. The project shall also describe how this support can be provided to academia, industry and healthcare.

Time plan

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