Aid that finances 50% of regulatory and clinical quality services

BPI, in collaboration with an ecosystem of qualified experts, provides, with this system, an appropriate response to address current quality and regulatory issues.

Presentation of the “Diag medical device”

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:

The implementation of their quality management system according to ISO 13485:2016
Obtaining a CE marking (EU Regulations 2017/745 and 2017/746 )
The design of a clinical and/or medico-economic investigation protocol

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 .

Help for start-ups and SMEs

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:

For quality management systems according to ISO 13485, this concerns all MD/IVDM and not just digital or connected MD
For the creation or updating of technical documentation within the framework of CE marking, this concerns all MD/IVDM

Assistance in line with the challenges of regulatory manufacturers

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.

How can we support you?

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:

Jérémy HABECKER, Quality Manager
Lauriane SAUGE, Regulatory Affairs Manager

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 .