GlucoTrack (GCTK) Announces ISO 13485:2016 Certification

Glucotrack, Inc. (Nasdaq: GCTK) today announced that it has received ISO 13485:2016 certification from the British Standards Institute (BSI).

“This ISO certification is a major step in our journey toward delivering high-quality products,” said Paul V. Goode, PhD, President and Chief Executive Officer. “Meeting these rigorous global standards for design and manufacturing demonstrates our dedication to quality and regulatory excellence as we continue to achieve clinical and developmental milestones for our revolutionary Continuous Blood Glucose Monitor (CBGM) for people with diabetes.”

The Company successfully completed Stage I and Stage II Assessments performed by the notified body, BSI, to verify it has established, and is maintaining, a quality management system that meets all requirements of the ISO 13485:2016 standard for design and development of the Company’s products.

ISO 13485 is an internationally recognized standard for quality management systems, created by the International Organization for Standardization to ensure the safety and effectiveness of medical devices. It builds on the ISO 9001 standard with additional regulatory requirements specific to medical devices. In 2024, the U.S. Food and Drug Administration issued the Quality Management System Regulation (QMSR) Final Rule, which harmonizes U.S. requirements with global standards through the adoption of ISO 13485 for medical devices. ISO 13485 is also strongly recommended and widely used in the European Union.

For more information about Glucotrack’s CBGM, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.

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