Endotronix Receives ISO Certification for its Innovative QMS solution
By MedTech Outlook | Friday, April 26, 2019
Historically, heart failure management has been a costly, reactive care model focused on the hospital or office setting that leads to poor long-term patient outcomes. For successful heart failure management, Endotronix is the way beyond the traditional care models. The Illinois-based digital health and medical technology company delivers efficient solutions for advancing the treatment of heart failure. The company adheres to the highest level of internationally recognized standards that have helped the company to carve a niche for itself across the medical device industry. In the recent development, Endotronix has received ISO 13485:201 certification from the British Standards Institution (BSI) for its innovative Quality Management System (QMS).
Harry Rowland, CEO of Endotronix said, “We are focused on executing several key businesses, regulatory, and clinical milestones this year that ultimately drive the success of the company. The recent ISO certification ensures we are fully aligned with global regulatory requirements to provide a best-in-class product quality experience to our customers.” “Similarly, we continue to make excellent progress with our comprehensive clinical program, which will show the real-world benefits of the Cordella System and create U.S. and E.U. market access for the Cordella Sensor,” extols Harry.
Traditionally, heart failure management has been a costly, reactive care model that focuses primarily on the hospital and an office setting that leads to poor long-term patient outcomes. Endotronix looks beyond the conventional care model to provide a data-driven patient management solution called Cordella Heart Failure System. The solution enables broader use of guideline-directed medical therapy to improve patient outcomes. Endotronix also enables heart failure patients to collect daily clinic-grade patient data like blood pressure, weight, heart rate, blood oxygen, ECG, and other patient symptoms through its patient-friendly tablet. Endotronix allows the Cordella system to be seamlessly integrated with a next-generation pulmonary artery pressure sensor, the Cordella Sensor, which helps to streamline heart failure care management. The integration also helps to reduce heart-failure-related hospitalizations, and support reimbursement for care delivery activities.