D-Heart Customer Care
Quality and Regulatory Manager
Strena Medical Srl SB
Genova, Italy
RemoteTechnology/solution provider / Startup
I am the quality and regulatory manager for the D-Heart product (portable ECG). I was able to re-certify the medical device according to the new MDR regulation
My organisation
Strena Medical Srl SB is an innovative SME that designs and manufactures the portable electrocardiograph D-Heart, an ECG device capable of recording both 8 and 12 leads and CE certified for use in both home and professional environments. Thanks to its App, which guides users through the correct ECG acquisition, anyone—even patients with no medical knowledge—can perform a high-quality 8-lead ECG. The device also offers the ability to record 12-lead ECGs for all categories of healthcare professionals working outside hospital settings. Due to its innovative technology, extreme portability, and affordability, D-Heart is chosen by many professionals to record hospital-grade 12-lead ECGs on their patients. Moreover, through the D-Heart App, a 24/7 telecardiology service is available. This service allows users to request a report analyzed and signed by a cardiologist. The report is delivered within 15 minutes of being sent to the telecardiology service. The portable ECG D-Heart has won numerous awards for its innovative design, including the Red Dot Design Award and the Compasso D’Oro, Strena Medical’s goal is to increase the use of self-monitoring tools and telemedicine, and to raise patient awareness regarding heart health.