Case Study

At the Heart of IEC 62304 Medical Device Embedded Software Testing

At the Heart of IEC 62304 Medical Device Embedded Software Testing

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Terumo Heart dedicates its efforts to the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Its primary focus is their life-saving DuraHeartTM Left Ventricular Assist System (LVAS) device, an implantable device that combines patented magnetic levitation and centrifugal pump technologies to assist the left side of the heart in pumping blood. The DuraHeart LVAS improves circulation throughout the body; decreasing the risk of cell damage and its associated complications. T erumo entrusted VectorCAST platform to support continuous improvement of DuraHeart in order to better ensure software quality, demonstrate due diligence, and comply with IEC 62304 guidelines. Success Story Terumo Heart At the Heart of IEC 62304 Medical Device Em

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