Presentation

IRI-CE is a consulting agency specializing in Regulatory Affairs and Quality Management entirely dedicated to medical devices.

With our expertise in Regulatory Affairs, we support your teams and your company in their projects to obtain CE marking and regulatory authorizations.

Our additional expertises in Quality Management allows you to support your teams and your company in their certifications projects (ISO 13485, MDSAP, FDA).

Our Agency offers an personalized approach adapted to your products/service(s) and the size of your company.

Our main assets are based on expertise, technical skills and responsiveness.

Our challenge is to increase the skills of your teams to achieve your goals.