FineHeart certified ISO 13485 : 2016 for Medical Device Quality Management Systems
Bordeaux, France, September 5, 2022 – FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, a fully Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from severe heart failure, today announced its ISO 13485 : 2016 certification. This certifies the compliance of FineHeart’s quality management system with medical device industry regulations and has been issued following an audit by BSI, the independent, internationally recognized, accreditation organization.