GlySure Earns ISO 13485 Certification
GlySure March 2013
Achievement marks key progress toward European regulatory trials
GlySure Limited, developer of in-hospital continuous blood glucose monitoring systems, today announced that it has achieved ISO 13485 certification, the global standard for the requirements of a quality management system for the design, manufacture and distribution of medical devices. By establishing a quality management system that meets international regulatory and customer requirements, GlySure has set the foundation for its European clinical trials.
“This is an exciting time for our company as we conclude our prototype trials and turn our sights toward securing a CE mark,” said GlySure CEO Chris Jones. “ISO 13485 certification is a key step in this transition as it validates our quality management system and ability to consistently deliver safe and effective technologies to the global marketplace.”
GlySure’s continuous blood glucose monitoring (CBGM) technologymeets the clinically documented need for Tight Glycemic Control (TGC) in the Intensive Care Unit (ICU), which has been shown to improve outcomes, reduce mortality and cut the cost of care.
ISO certification is the latest in a series of recent key achievements for GlySure as it prepares for regulatory trials. Over the past year the company has expanded its manufacturing, quality and development teams, opened a new manufacturing facility in Oxfordshire, England and is nearing completion of pre-clinical trials in over 120 ICU patients. GlySure anticipates that it will begin CE mark trials of its CGM system in the second quarter of 2013.