Treatment of Severe Heart Failure - AI: FineHeart Reinforces Its Industrial Credentials and Long-Term Strategy by Adding Manufacturing to Its ISO 13485: 2016 Certification

BORDEAUX, France--(BUSINESS WIRE)--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®.

Issued following an audit conducted by BSI, an independent notified body of international reference, this certification validates the robustness of the quality management system implemented by the company over the last 10 years. Hitherto limited to R&D activities, the extension of ISO 13485:2016 certification to manufacturing is an essential milestone in FineHeart's industrialization phase and reinforces its long-term strategy.

Arnaud Mascarell, CEO and co-founder of FineHeart, commented: "This new certification illustrates the maturity of our quality management and the reliability of our industrial processes, which will be deployed at our future production site. The new manufacturing facility and head office, which is currently under construction near Bordeaux, will centralize research and development, performance testing and all the industrial processes needed to produce the FlowMaker® for future commercial supply.”

Sophie Jonquière, Purchasing and Supply Chain Director, comments: "The extension of our ISO 13485:2016 certification demonstrates FineHeart's ability to ensure a reliable supply chain and to implement a unique industrial tool at the service of its breakthrough technology. It validates the robustness of our FlowMaker® manufacturing processes, which meet the highest standards of sanitary quality, notably for our clinical trials currently underway in Europe, and future CE marking and PMA studies in the United States."

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