Glucotrack Announces ISO 13485:2016 Certification
Glucotrack (Nasdaq: GCTK) has achieved ISO 13485:2016 certification from the British Standards Institute (BSI), marking a significant milestone in its development of continuous blood glucose monitoring technology. The certification validates the company's quality management system for medical device design and development.
The achievement follows successful completion of Stage I and Stage II Assessments by BSI, confirming Glucotrack's compliance with ISO 13485:2016 standards. This internationally recognized certification is particularly significant given the FDA's 2024 Quality Management System Regulation Final Rule, which aligns U.S. requirements with global standards through ISO 13485 adoption.
CEO Paul V. Goode emphasized this certification's importance in their journey toward delivering high-quality Continuous Blood Glucose Monitor (CBGM) products for people with diabetes, highlighting the company's commitment to quality and regulatory excellence.
Glucotrack (Nasdaq: GCTK) ha ottenuto la certificazione ISO 13485:2016 dall'Istituto Britannico degli Standard (BSI), segnando un importante traguardo nello sviluppo della tecnologia di monitoraggio continuo della glicemia. La certificazione convalida il sistema di gestione della qualità dell'azienda per la progettazione e lo sviluppo di dispositivi medici.
Il risultato è stato conseguito dopo il completamento positivo delle valutazioni di Fase I e Fase II da parte del BSI, confermando la conformità di Glucotrack agli standard ISO 13485:2016. Questa certificazione, riconosciuta a livello internazionale, è particolarmente significativa considerando la Regola Finale del Regolamento sul Sistema di Gestione della Qualità della FDA del 2024, che allinea i requisiti statunitensi agli standard globali attraverso l'adozione di ISO 13485.
Il CEO Paul V. Goode ha sottolineato l'importanza di questa certificazione nel loro percorso verso la fornitura di prodotti di alta qualità Monitor di Glicemia Continuo (CBGM) per le persone con diabete, evidenziando l'impegno dell'azienda per l'eccellenza qualitativa e normativa.
Glucotrack (Nasdaq: GCTK) ha conseguido la certificación ISO 13485:2016 del Instituto Británico de Normas (BSI), marcando un hito significativo en su desarrollo de tecnología de monitorización continua de glucosa en sangre. La certificación valida el sistema de gestión de calidad de la empresa para el diseño y desarrollo de dispositivos médicos.
El logro sigue a la finalización exitosa de las Evaluaciones de Etapa I y Etapa II por parte del BSI, confirmando la conformidad de Glucotrack con los estándares ISO 13485:2016. Esta certificación, reconocida a nivel internacional, es especialmente significativa dada la Regla Final del Reglamento del Sistema de Gestión de Calidad de la FDA de 2024, que alinea los requisitos de EE.UU. con estándares globales mediante la adopción de ISO 13485.
El CEO Paul V. Goode enfatizó la importancia de esta certificación en su camino hacia la entrega de productos de alta calidad Monitores de Glucosa en Sangre Continuos (CBGM) para personas con diabetes, subrayando el compromiso de la empresa con la calidad y la excelencia regulatoria.
글루코트랙 (Nasdaq: GCTK)은 영국 표준 협회(BSI)로부터 ISO 13485:2016 인증을 획득하며 지속적인 혈당 모니터링 기술 개발에 있어 중요한 이정표를 세웠습니다. 이 인증은 의료 기기 설계 및 개발을 위한 회사의 품질 관리 시스템을 검증합니다.
이 성과는 BSI의 1단계 및 2단계 평가의 성공적인 완료 후 이루어졌으며, 글루코트랙이 ISO 13485:2016 기준을 준수함을 확인했습니다. 이 국제적으로 인정받는 인증은 FDA의 2024 품질 관리 시스템 규정 최종 규칙과 관련하여 특히 중요하며, 미국 요구 사항을 ISO 13485 채택을 통해 글로벌 표준에 맞추고 있습니다.
CEO 폴 V. 구드(Paul V. Goode)는 당사 제품이 당뇨병 환자를 위한 지속적인 혈당 모니터(CBGM)을 제공하는 과정에서 이 인증의 중요성을 강조하며, 품질과 규제 탁월성에 대한 회사의 헌신을 부각시켰습니다.
Glucotrack (Nasdaq: GCTK) a obtenu la certification ISO 13485:2016 de l'Institut Britannique des Normes (BSI), marquant une étape importante dans le développement de sa technologie de surveillance continue de la glycémie. La certification valide le système de gestion de la qualité de l'entreprise pour la conception et le développement de dispositifs médicaux.
Cette réalisation fait suite à la réussite des évaluations de la Phase I et de la Phase II par le BSI, confirmant la conformité de Glucotrack aux normes ISO 13485:2016. Cette certification, reconnue au niveau international, est particulièrement significative compte tenu de la Règle Finale du Règlement des Systèmes de Gestion de la Qualité de la FDA de 2024, qui aligne les exigences américaines avec les normes mondiales grâce à l'adoption de l'ISO 13485.
Le PDG Paul V. Goode a souligné l'importance de cette certification dans leur parcours vers la fourniture de produits de haute qualité Moniteurs de Glycémie Continus (CBGM) pour les personnes diabétiques, mettant en avant l'engagement de l'entreprise envers la qualité et l'excellence réglementaire.
Glucotrack (Nasdaq: GCTK) hat die ISO 13485:2016-Zertifizierung vom British Standards Institute (BSI) erhalten, was einen bedeutenden Meilenstein in der Entwicklung seiner Technologie zur kontinuierlichen Überwachung des Blutzuckers darstellt. Die Zertifizierung bestätigt das Qualitätsmanagementsystem des Unternehmens für das Design und die Entwicklung medizinischer Geräte.
Dieser Erfolg folgt auf den erfolgreichen Abschluss der Stufen I und II Bewertungen durch das BSI, der die Konformität von Glucotrack mit den Standards ISO 13485:2016 bestätigt. Diese international anerkannte Zertifizierung ist besonders bedeutend angesichts der endgültigen Regelung des FDA-Regelwerks für Qualitätsmanagementsysteme von 2024, die die Anforderungen der USA mit globalen Standards durch die Annahme von ISO 13485 in Einklang bringt.
Der CEO Paul V. Goode betonte die Bedeutung dieser Zertifizierung auf ihrem Weg zur Bereitstellung hochwertiger Kontinuierliche Blutzucker-Monitore (CBGM) für Menschen mit Diabetes und hob das Engagement des Unternehmens für Qualität und regulatorische Exzellenz hervor.
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ISO Certification highlights commitment to quality for continuous blood glucose monitor
RUTHERFORD, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, 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.
About Glucotrack, Inc.
Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.
Glucotrack’s CBGM is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. For more information, please visit http://www.glucotrack.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 28, 2024.
Contacts:
Investor Relations:
investors@glucotrack.com
Media:
GlucotrackPR@icrinc.com
FAQ
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