May 2, 2012
Glytec Achieves ISO Certification
Glytec is the first company to achieve this medical device certification in the glycemic management product space.
Greenville, SC — Glytec, LLC, a privately held medical software company, announced that it has achieved the ISO 13485:2003 Certification for its quality management and assurance processes for the safe design, production and installation of Glucommander 2.0 Enterprise software. Glytec is the first company to achieve this medical device certification in the glycemic management product space.
ISO is the world’s largest, most credible and relied upon process standards organization. The entire ISO process is designed around creating better customer results. By accepting the ISO challenge, an organization must agree to internal and external annual surveillance audits and an in-depth recertification audit every five years.
According to Trefor Thomas, Glytec CEO and President, “Achieving this certification says we are serious about patient safety; and it demonstrates to our internal team, our stakeholders and the marketplace that we are committed to achieving the highest levels of product quality and organizational effectiveness. When safety is our focus, everyone wins, from the patient to the medical staff and the hospital overall.”
ISO (International Organization for Standardization) is the world’s largest developer and publisher of international standards. It is a network of national standards institutes from 162 countries, with a central secretariat in Geneva, Switzerland, that coordinated the international system. The ISO medical device requirements are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug and Cosmetic Act.
Founded in 2006 and headquartered in Greenville, South Carolina, Glytec (www.glytecsystems.com) is leading the way with next generation glycemic control management systems. Glytec offers the only glycemic management system cleared for both adults and children.