Biora Therapeutics Achieves ISO 13485 Certification
Biora Therapeutics (Nasdaq: BIOR) has achieved ISO 13485:2016 certification, demonstrating its commitment to global regulatory and quality standards. The certification, awarded by TÜV SÜD America, verifies Biora's robust quality management system for design, development, manufacturing, and distribution of its products.
CEO Adi Mohanty emphasized the significance of this achievement in meeting regulatory requirements as the company progresses with its NaviCap™ and BioJet™ platforms. ISO 13485 is an internationally recognized standard for medical device quality management systems, building upon ISO 9001 with additional regulatory requirements.
This certification aligns with the FDA's 2024 Quality Management System Regulation Final Rule, which harmonizes U.S. requirements with global standards through the adoption of ISO 13485 for medical devices.
Biora Therapeutics (Nasdaq: BIOR) ha ottenuto la certificazione ISO 13485:2016, dimostrando il suo impegno verso gli standard normativi e di qualità globali. La certificazione, rilasciata da TÜV SÜD America, verifica il robusto sistema di gestione della qualità di Biora per la progettazione, lo sviluppo, la produzione e la distribuzione dei suoi prodotti.
Il CEO Adi Mohanty ha sottolineato l'importanza di questo traguardo nel soddisfare i requisiti normativi mentre l'azienda avanza con le sue piattaforme NaviCap™ e BioJet™. La ISO 13485 è uno standard riconosciuto a livello internazionale per i sistemi di gestione della qualità dei dispositivi medici, che si basa sulla ISO 9001 con requisiti normativi aggiuntivi.
Questa certificazione è allineata con la Regola Finale sulla Regolamentazione del Sistema di Gestione della Qualità della FDA per il 2024, che armonizza i requisiti statunitensi con gli standard globali tramite l'adozione della ISO 13485 per i dispositivi medici.
Biora Therapeutics (Nasdaq: BIOR) ha conseguido la certificación ISO 13485:2016, lo que demuestra su compromiso con los estándares regulatorios y de calidad globales. La certificación, otorgada por TÜV SÜD America, verifica el sólido sistema de gestión de calidad de Biora para el diseño, desarrollo, fabricación y distribución de sus productos.
El CEO Adi Mohanty destacó la importancia de este logro en el cumplimiento de los requisitos regulatorios a medida que la empresa avanza con sus plataformas NaviCap™ y BioJet™. La ISO 13485 es un estándar reconocido internacionalmente para los sistemas de gestión de calidad de dispositivos médicos, que se basa en la ISO 9001 con requisitos regulatorios adicionales.
Esta certificación está alineada con la Regulación Final del Sistema de Gestión de Calidad de la FDA para 2024, que armoniza los requisitos de EE. UU. con los estándares globales a través de la adopción de la ISO 13485 para dispositivos médicos.
비오라 테라퓨틱스 (Nasdaq: BIOR)는 ISO 13485:2016 인증을 획득하여 글로벌 규제 및 품질 기준에 대한 헌신을 입증하였습니다. TÜV SÜD America에서 수여한 이 인증은 비오라의 제품 설계, 개발, 제조 및 유통에 대한 견고한 품질 관리 시스템을 검증합니다.
CEO 아디 모한티는 회사가 NaviCap™ 및 BioJet™ 플랫폼을 발전시키면서 규제 요건을 충족하는 데 있어 이 성과의 중요성을 강조했습니다. ISO 13485는 의료 기기 품질 관리 시스템을 위한 국제적으로 인정된 표준으로, ISO 9001을 기반으로 추가적인 규제 요건을 포함합니다.
이 인증은 FDA의 2024 품질 관리 시스템 규정 최종 규칙과 일치하며, 이는 의료 기기를 위한 ISO 13485의 채택을 통해 미국의 요구 사항을 글로벌 표준과 조화시킵니다.
Biora Therapeutics (Nasdaq: BIOR) a obtenu la certification ISO 13485:2016, démontrant son engagement à respecter les normes réglementaires et de qualité mondiales. La certification, accordée par TÜV SÜD America, vérifie le solide système de gestion de la qualité de Biora pour la conception, le développement, la fabrication et la distribution de ses produits.
Le PDG Adi Mohanty a souligné l'importance de cette réalisation pour répondre aux exigences réglementaires alors que l'entreprise progresse avec ses plateformes NaviCap™ et BioJet™. La norme ISO 13485 est une norme reconnue internationalement pour les systèmes de gestion de la qualité des dispositifs médicaux, s'appuyant sur l'ISO 9001 avec des exigences réglementaires supplémentaires.
Cette certification est alignée avec la Règle Finale de la Réglementation du Système de Gestion de la Qualité de la FDA pour 2024, qui harmonise les exigences américaines avec les normes mondiales par l'adoption de l'ISO 13485 pour les dispositifs médicaux.
Biora Therapeutics (Nasdaq: BIOR) hat die ISO 13485:2016-Zertifizierung erhalten, die ihr Engagement für globale regulatorische und Qualitätsstandards demonstriert. Die Zertifizierung, die von TÜV SÜD America vergeben wurde, bestätigt das robuste Qualitätsmanagementsystem von Biora für die Gestaltung, Entwicklung, Herstellung und den Vertrieb ihrer Produkte.
CEO Adi Mohanty betonte die Bedeutung dieses Erfolgs für die Erfüllung der regulatorischen Anforderungen, während das Unternehmen mit seinen NaviCap™ und BioJet™ Plattformen voranschreitet. Die ISO 13485 ist ein international anerkanntes Standard für Qualitätsmanagementsysteme von Medizinprodukten, das auf der ISO 9001 basiert und zusätzliche regulatorische Anforderungen beinhaltet.
Diese Zertifizierung stimmt mit dem endgültigen Regelwerk zur Regulierung des Qualitätsmanagementsystems der FDA von 2024 überein, das die US-Anforderungen mit globalen Standards durch die Einführung der ISO 13485 für Medizinprodukte harmonisiert.
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Underscoring the company’s commitment to quality and excellence
SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced it has been awarded ISO 13485:2016 certification by TÜV SÜD America, demonstrating the company’s commitment to compliance with the most rigorous global regulatory and quality standards.
“We are proud of the robust systems our team has built, ensuring stringent control over development and manufacturing processes,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “This certification demonstrates our ongoing ability to meet exacting regulatory requirements as we continue to achieve clinical and developmental milestones for the NaviCap™ and BioJet™ platforms.”
Biora successfully completed audits by TÜV SÜD America to verify that it has established and is maintaining a quality management system that meets all requirements of the ISO 13485:2016 standard for design, development, manufacturing, and distribution of Biora’s products.
ISO 13485 is an internationally recognized quality 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 standards for medical devices.
About Biora Therapeutics
Biora Therapeutics is a clinical-stage biotech developing two smart pill-based therapeutics platforms: the NaviCap™ platform for colon-targeted treatment of IBD, designed to improve patient outcomes through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ platform for oral delivery of large molecules, designed to replace injection with needle-free, oral delivery with minimal changes to standard liquid formulations.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn or X.
Safe Harbor Statement or Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development, preclinical and clinical trial activities, including those involving BT-600 and our NaviCap platform and model-based data projections for the BT-600 program, and partnering and collaboration efforts with third parties, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “envision,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “anticipate,” “forward,” “believe,” “design,” “estimate,” “predict,” “projects,” “projecting,” “potential,” “plan,” “goal(s),” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future FDA filings and initiate and execute clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators or partners, our ability to raise sufficient capital to achieve our business objectives, our ability to maintain our listing on the Nasdaq Global Market, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) and other subsequent documents, including Quarterly Reports on Form 10-Q, that we file with the SEC.
Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390
Media Contact
Liz Robinson
CG Life
lrobinson@cglife.com
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