Chester County-based Glutalor Medical Announces ISO 13845 Certification

Chester County-based Glutalor Medical Announces ISO 13845 Certification

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.

Chester County-based Glutalor Medical Announces ISO 13845 Certification

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.”

总部位于切斯特县的Glutalor Medical宣布获得ISO 13845认证

宾夕法尼亚州EXTON —专注于连续葡萄糖监测设备（CGM）的开发和制造的总部位于切斯特县的医疗技术公司Glutalor Medical宣布，该公司已满足其医疗设备和质量管理体系通过ISO 13845认证的要求。

ISO 13845是医疗器械行业质量管理最广泛使用的国际标准，并且是主要在欧盟将医疗产品商业化的医疗器械生产的法规标准。

Glutalor Medical于2020年5月29日通过了ISO 13845认证审核。GlutalorMedical的旗舰产品iWEL®CGM系统通过智能手机将简单可靠的感测，自动化的轻松监控和建议以及通过云计算的相关参数进行集中健康分析基于解决方案。

该认证使宾州宾夕法尼亚州埃克斯顿市的最先进的自动化生产线能够为其他市场制造CGM传感器。

Glutalor Medical质量与监管副总裁Garry Courtney说：“我们很荣幸获得ISO 13845认证，这是对我们遵守全球医疗器械行业法律和法规要求的认可。” “该认证说明了公司对质量，安全性和性能的持续承诺，并且是公司通过改善糖尿病管理支持和控制为全球患者提供基于价值的保健服务的重要里程碑。”

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