We improve the Quality of Life for People with Diabetes.

Quality Management

Sensile Medical is commited to rigorous quality management (QM). The quality system we have established will ensure the highest possible standards and safety of our products.

Sensile Medical’s quality management system is in accordance with the ISO 13485:2003 and ISO 9001:2000 standard and to the FDA/cGMP requirements (QSR 820) for medical devices. Certification of the quality management system according to ISO 13485:2003 and ISO 9001:2000 is in place since November 2007, as it pertains to our unique business needs and operations.

The early implementation of our quality management system will support the international registration of Sensile Medical’s medical device products in a later phase.