Monarch Medical Technologies, a US-based medical technology company, has obtained ISO 13485:2003 certification for its quality management system from the independent certifying body, Nemko.
As per the ISO 13485:2003 requirements of the quality management system, an organization should show its ability to serve medical devices and related services that consistently meet the customer requirements.
Monarch’s flagship product is the EndoTool glucose management system, which is reportedly the only technology that facilitates rapid and sustained glucose control in 99.4% of patients and maintains glucose levels within target range as much as 97.25% of the time after control is attained.
Unlike paper-based and traditional computer-based protocols, EndoTool is the only glucose management software solution that is customized to each patient’s unique physiology and individual response.
Monarch Medical Technologies CEO Dr Wilson Constantine noted receiving ISO 13485:2003 certification confirms that company’s quality standards are among the best in the medical device industry.
"It is also another important step in our plan to expand our market-leading position in the U.S. to overseas markets," Dr Constantine added.