Diag DM, a subsidy for medical device manufacturers

Accessible from class IIa , Diag DM is a device which allows you to benefit from 50% coverage of services allowing you to:

• Part 1: Implement a quality management system according to ISO 13485
• Section 2: Constitute or upgrade technical documentation within the framework of CE marking
• Part 3: Carry out a clinical study protocol.

Our two experts referenced by BPI will be able to support you on sections 1 (QMS) and 2 (Technical documentation).

For information purposes, you will find below the amounts eligible for this 50% aid:

Extract from the specifications published by BPI France given for information purposes only and subject to updating by the organization.

With this system, BPI sets up a tripartite contract between BPI, the manufacturer and the referenced service provider. Within Cisteo, two experts are referenced by BPI:

• Lauriane Sauge, quality service and regulatory affairs manager
• Jérémy Habecker, quality manager

Each manufacturer can submit a file per section and request in particular the support of the following services:

• Preparation of technical documentation for a medical device IIa, IIb and III
• Drafting and adapting a quality management system to be as close as possible to its activities
• Upgrade of technical documentation to facilitate the transition to EU Regulation 2017/745 (MDR)

Training a member of the quality team is also eligible for the system when implementing the QMS.