Company Overview - Glucotrack Inc is a medical technology company focused on designing, developing, and commercializing novel technologies for people with diabetes [5] - The company is currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system for diabetes patients [5] - The CBGM system features a 3-year sensor longevity, no on-body wearable component, and requires minimal calibration [6] ISO Certification Achievement - Glucotrack has received ISO 13485:2016 certification from the British Standards Institute (BSI) [1] - The certification demonstrates the company's compliance with rigorous global standards for medical device design and manufacturing [2] - ISO 13485 is an internationally recognized quality management standard specifically for medical devices, building upon ISO 9001 with additional regulatory requirements [3] - The certification aligns with the U.S. FDA's Quality Management System Regulation (QMSR) Final Rule issued in 2024, which harmonizes U.S. requirements with global standards [3] Product Development - The company has successfully completed Stage I and Stage II Assessments by BSI, verifying its quality management system meets ISO 13485:2016 standards [2] - Glucotrack's CBGM represents a revolutionary approach to continuous blood glucose monitoring for diabetes patients [2] - The company continues to achieve clinical and developmental milestones for its CBGM system [2]
Glucotrack Announces ISO 13485:2016 Certification