Monarch Medical Technologies Achieves ISO 13485 Certification

Monarch Medical Technologies, the leader in precision insulin dosing for optimized inpatient glucose management, has earned ISO 13485:2016 certification for its quality management system from the independent certifying body, TÜV SÜD. The international quality standard containing multiple criteria for the whole range of a medical device manufacturer’s quality management system, ISO 13485:2016 certifies Monarch’s ability to offer medical devices and related services that consistently meet applicable customer needs and regulatory requirements.

“Receiving ISO 13485:2003 certification has demonstrated Monarch’s commitment to attaining the highest quality standards and I’m extremely proud of our team for this achievement,” said Christophe Mallard, chief executive officer of Monarch Medical Technologies. “Our team is dedicated to constant improvement and development and achieving and maintaining an ISO 13485:2016 accreditation ensures we have the processes and systems needed to be successful.”

Monarch’s flagship product is the EndoTool® Glucose Management System, a leading glucose management software solution for healthcare institutions. It is designed to achieve rapid and sustained control in even the most complex patient cases, including those with sepsis, burns, DKA and HNS. With safe and personalized insulin dosing recommendations based on physiological patient-specific factors and individual patient’s response to treatment, EndoTool helps patients achieve glycemic control and optimize patient outcomes. EndoTool’s proprietary Model Predictive Control technology allows for unsurpassed optimization in patient-specific dosing, significantly improving quality of care, reducing risk and controlling healthcare costs.

About Monarch Medical Technologies

More than 300 U.S. hospitals rely on patented solutions from Monarch Medical Technologies for safe and effective inpatient glycemic management. The company’s FDA-cleared EndoTool® Glucose Management System offers clinicians real-time clinical decision support in the form of personalized dosing recommendations for intravenous and subcutaneous insulin therapies. The platform integrates seamlessly with all major electronic medical record systems and is available through a software-as-a-service (SaaS) subscription. Monarch Medical Technologies was founded in 2006 and is headquartered in Charlotte, North Carolina. For more information, visit