ISO 13485 : an expanded scope

Last February, we obtained and renewed the ISO 13485 certification dedicated to the medical devices on our Normandy’s site in Eu. A novelty this year, because the design and the development phases are integrated to the certification scope. We can now be involved with our customers & partners from early stages of their projects.

For many years now, our plant Einea in Normandy is accredited ISO13485, a required passeport to collaborate to medical devices production. This year, in the context of this certification, we obtained the integration of the design and development scope. In practice, this means that we cover now the medical device developement from the first idea to the realisation.

Thanks to our internal design office and the engineering team, we have both the experience, expertise, quality environment and means to concrete our customer needs.