Diagnostics and regulatory processes
Supporting project leaders in their regulatory, quality, and clinical processes
What is the purpose of this action?
As of 2022, project leaders can be financially supported in setting up a quality process, obtaining a CE mark or developing a clinical (or cost-effectiveness) study.
This support, provided through BPI France, has a budget of €20 million.
Who is it for ?
The ecosystem of entrepreneurs
H1 2022 System launch
eHealth project leaders are faced with regulatory and demonstration issues that are sometimes very complicated to address. Many projects do not reach the end of their development and market access because of the difficulty and cost of setting up a quality process, obtaining a medical device CE marking if necessary, and successfully completing a quality clinical study. These difficulties are even greater for project leaders who are unfamiliar with these issues, hindering the transfer of technologies
This action aims to financially support project leaders in their work to set up a quality process, obtain a CE mark or develop a clinical (or cost-effectiveness) study, and thus to enable project leaders to reach sufficient maturity to carry out the clinical studies required for market access.
Project leaders will use a specialized external agency or consultant. A call for applications is open from August 23 to September 23, 2022.
This action will take the form of a continuous portal operated by BPIfrance. This portal will be opened in the second half of 2022.
At the same time, actions aimed at developing and specializing the regulatory support options available may be carried out.
Can I apply for the action?
Amount associated with the action
Does it fund projects?
How does one apply?
Applications will be opened once the system launches
Roadmap of the action