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Glucotrack receives ISO 13485:2016 certification for quality management system
Glucotrack, Inc.
- Certification awarded by British Standards Institute after Stage I and Stage II assessments.
- Covers design and development of Glucotrack's long-term implantable Continuous Blood Glucose Monitor (CBGM).
- ISO 13485 is the globally recognized standard for medical device QMS, aligned with FDA QMSR and used in the EU.
- CEO Paul Goode calls certification a major step toward delivering high-quality products.
- No financial updates or guidance changes provided in the announcement.