EXTON, PA — Glutalor Medical, a Chester County-based medical technology company focused on the development and manufacturing of continuous glucose monitoring devices (CGM), announced that the Company has satisfied the requirements for ISO 13845 certification for its medical device and quality management systems.
ISO 13845 is the most widely used international standard for quality management in the medical device industry and is the regulatory standard for manufacturing medical devices with intention of commercialization of medical products mainly in EU.
Glutalor Medical passed the ISO 13845 certification audit on May 29, 2020. Glutalor Medical’s flagship product, the iWEL® CGM system, brings together simple reliable sensing, automated easy monitoring and advice via smart phone, and central health analytics of relevant parameters via a cloud-based solution.
This certification enables the manufacture of CGM sensors for other markets with its state-of-the-art automated production line in its Exton, Pennsylvania facility.
“We are proud to have received our ISO 13845 certification, recognizing our compliance with the legal and regulatory requirements of the global medical device industry,” said Garry Courtney, Vice President of Quality and Regulatory at Glutalor Medical. “This certification illustrates the company’s continued commitment to quality, safety, and performance, and is an important milestone in the company’s efforts to bring value-based health care to patients around the world through improved diabetes management support and control.”
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