Monarch Medical Technologies Achieves ISO 13485 Certification
Monarch Medical Technologies, the pioneer and leader in mitigating risk associated with drugs and processes of concern in hospitalized patients, has earned ISO 13485:2003 certification for its quality management system from the independent certifying body, Nemko. The international quality standard containing multiple criteria for the whole range of a medical device manufacturer’s quality management system, ISO 13485:2003 certifies Monarch’s ability to offer medical devices and related services that consistently meet applicable customer needs and regulatory requirements.
Monarch’s flagship product is the EndoTool Glucose Management System, the market-leading software solution that provides unsurpassed patient-specific glycemic control across a broad population of patients. Unlike paper-based and traditional computer-based protocols, EndoTool is the only glucose management software solution that models, predicts and adapts insulin dosing to each patient’s unique physiology and individual response. With the system’s proprietary Model Predictive Control technology, 99.4 percent of patients achieve control1 , and glucose levels remain within target range as much as 97.25 percent of the time after control is achieved.1
“Receiving ISO 13485:2003 certification confirms that our quality standards are among the best in the medical device industry,” said Dr. Wilson Constantine, chief executive officer of Monarch Medical Technologies. “It is also another important step in our plan to expand our market leading position in the U.S. to overseas markets.”
Since it was acquired by private investment firm Eigen Capital in October 2012, Monarch has accomplished several other significant achievements, including: the appointment of Dr. Constantine, a medical device industry veteran, as CEO; a successful company rebranding from EndoTool LLC to Monarch Medical Technologies, debuted at the 2013 National Teaching Institute & Critical Care Exposition in May; and, the development of a next generation version of EndoTool, enhancing the most tested glucose management software solution in the industry with several entirely new features and benefits (pending clearance from the U.S. Food and Drug Administration).
About Monarch Medical Technologies
Monarch Medical Technologies is a privately held medical technology company founded by clinicians with a vision of dramatically improving hospital-based glucose management by replacing traditional paper and pencil linear protocols with individualized and predictive computer-based solutions. With the launch of its flagship product, the EndoTool Glucose Management System, the company pioneered the field of predictive therapeutic control technologies for managing drugs and processes of concern.
Formerly the EndoTool division of Hospira Worldwide, a leading Fortune 1000 healthcare company, the company was strategically acquired in October 2012 by private equity firm Eigen Capital Partners.
About EndoTool Glucose Management System
EndoTool Glucose Management System is the market-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. Unlike paperbased and traditional computer-based protocols, EndoTool is the only software solution of its kind that models, predicts and adapts insulin dosing to the individual patient. 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. Moreover, it gives healthcare providers the flexibility they need to support best practices and comply with continuous improvement initiatives. With EndoTool, 99.4 percent of patients achieve control1 and glucose levels remain within target range as much as 97.25 percent of the time after control is achieved.1
1. Multi-year experience of EndoTool customers; data on file.