BPI, in collaboration with an ecosystem of qualified experts, provides, with this system, an appropriate response to address current quality and regulatory issues.
In order to help start-ups and SMEs developing innovative medical devices, BPI France has set up the “Diag appareil médical” aid: this system helps regulatory manufacturers and finances half of the services relating to:
This system was created as part of the France 2030 plan, the objective of which is, in particular, to position France as a leader in the world of tomorrow and thus to support medical innovation throughout the life cycle of the system, from the idea to industrialization .
The system is aimed at start-ups and SMEs developing a medical device (MD) from class IIa to class III or an in vitro diagnostic medical device (IVDMD) from class B to class D.
Depending on the services, the type of device also comes into play:
Indeed, the development of a medical device requires the establishment of a mandatory framework, which is also necessary from the very beginning of the project. At a very early stage, when the medical device is still in its infancy, it is essential to begin the process of designing according to the applicable regulatory and normative requirements . The marketing will depend on the company's ability to ensure product performance and patient safety . It is therefore advisable to be able to quickly consider the implementation of its quality system as well as the constitution of its technical file , and what is more, to be able to finance them .
BPI, in collaboration with an ecosystem of qualified experts, provides, with this system, an appropriate response to address current quality and regulatory issues.
In order to facilitate its procedures, the manufacturer must call upon a referenced expert consultant .
BPI conducted a call for applications to provide manufacturers with qualified and experienced experts. Two people within Cisteo MEDICAL successfully met BPI's eligibility criteria:
They therefore become expert advisors and take charge of managing these files.
In our role as a partner, we are committed to working alongside medical device project leaders in order to support them in setting up and establishing these elements with a common objective: to meet in particular the requirements of the ISO 13485:2016 standard and the MDR 2017/745 .
Contact us