A key step : Manufacturing added to ISO 13485 :2016 certification
FineHeart reinforces its industrial credentials and long-term strategy by adding manufacturing to its ISO 13485: 2016 certification
Bordeaux, France, February 12, 2025 - FineHeart S.A., a clinical-stage medtech company developing
breakthrough solutions for cardiology, announces the extension of its ISO 13485:2016 certification to
cover all processes related to the production of its fully implantable cardiac assist device, the
FlowMaker®.