Call for applications for expert consultants to provide regulatory support for medical device project sponsors
Innovation
29/08/2022
Project developers of innovative medical devices and new digital health solutions areconfronted with regulatory and clinical demonstration issues that are essential to meet the demanding level of market access.
The guichet diagnostic " dispositif médical " aims to help DM, IVDD and digital DM companies set up a quality process, obtain a CE mark or develop a clinical (or medico-economic) investigation, and thus enable them to reach sufficient maturity to achieve the level of requirements required for market access.
The service will be provided by an external organization or consultant specialized in procedures for setting up a quality system, compiling a dossier to obtain a CE DM / IVDD mark and/or designing and writing clinical or medico-economic investigation protocols (ISO 14155 standard).
This call for applications is operated by BPI and is open until 23/09/2022. A Q&A session for applicants will be held on 08/09/2022 at 2 pm.
The "medical device" diagnostic window is financed as part of the France 2030 investment plan via the "Digital Health" acceleration strategy endowed with €670M and by the "medical devices" component endowed with €400M.