Microbot Medical Receives Quality Certification to Support Future Regulatory Submissions and Commercialization
Microbot Medical Inc. (Nasdaq: MBOT), developer of the LIBERTY® Endovascular Robotic Surgical System, has received ISO 13485:2016 certification for its quality management system. This certification validates the company's robust quality system and indicates compliance with specific medical industry standards for risk assessment and process management in regulated medical product development and manufacturing.
The ISO 13485 certification is viewed as an initial step towards European regulatory compliance under the new Medical Device Regulation (EU MDR) and is required for CE mark approval for sales in the European Union. It also aligns with the FDA's revised QMSR, potentially streamlining Microbot's transition into this updated regulation.
Microbot Medical Inc. (Nasdaq: MBOT), sviluppatore del sistema chirurgico robotico endovascolare LIBERTY®, ha ricevuto la certificazione ISO 13485:2016 per il proprio sistema di gestione della qualità. Questa certificazione convalida il robusto sistema di qualità dell'azienda e indica la conformità a specifici standard dell'industria medica per la valutazione del rischio e la gestione dei processi nello sviluppo e nella produzione di prodotti medici regolamentati.
La certificazione ISO 13485 è considerata un primo passo verso la conformità normativa europea ai sensi del nuovo Regolamento sui Dispositivi Medici (EU MDR) ed è necessaria per l'approvazione del marchio CE per le vendite nell'Unione Europea. Essa si allinea inoltre con la revisione del QMSR della FDA, potenzialmente semplificando la transizione di Microbot in questa regolamentazione aggiornata.
Microbot Medical Inc. (Nasdaq: MBOT), desarrollador del Sistema Quirúrgico Robótico Endovascular LIBERTY®, ha recibido la certificación ISO 13485:2016 por su sistema de gestión de calidad. Esta certificación valida el robusto sistema de calidad de la empresa e indica el cumplimiento de estándares específicos de la industria médica para la evaluación de riesgos y la gestión de procesos en el desarrollo y fabricación de productos médicos regulados.
La certificación ISO 13485 se ve como un primer paso hacia el cumplimiento regulador europeo bajo el nuevo Reglamento de Dispositivos Médicos (EU MDR) y es necesaria para la aprobación de la marca CE para ventas en la Unión Europea. También se alinea con la revisión de QMSR de la FDA, lo que podría agilizar la transición de Microbot a esta regulación actualizada.
Microbot Medical Inc. (Nasdaq: MBOT), LIBERTY® 혈관 내 로봇 수술 시스템의 개발업체는 품질 관리 시스템에 대한 ISO 13485:2016 인증을 받았습니다. 이 인증은 회사의 강력한 품질 시스템을 검증하고 위험 평가 및 프로세스 관리를 포함한 특정 의료 산업 기준을 준수함을 나타냅니다.
ISO 13485 인증은 새로운 의료기기 규제(EU MDR) 하에서 유럽 규제 준수를 위한 초기 단계로 간주되며, 유럽 연합에서 판매를 위한 CE 마크 승인에 필요합니다. 또한 FDA의 수정된 QMSR과 일치하여, Microbot이 이 업데이트된 규제로의 전환을 보다 원활하게 할 수 있도록 도울 수 있습니다.
Microbot Medical Inc. (Nasdaq: MBOT), développeur du Système Chirurgical Robotique Endovasculaire LIBERTY®, a obtenu la certification ISO 13485:2016 pour son système de gestion de la qualité. Cette certification valide le robuste système de qualité de l'entreprise et indique la conformité à des normes spécifiques de l'industrie médicale concernant l'évaluation des risques et la gestion des processus dans le développement et la fabrication de produits médicaux réglementés.
La certification ISO 13485 est considérée comme un premier pas vers la conformité réglementaire européenne selon le nouveau Règlement sur les Dispositifs Médicaux (EU MDR) et est requise pour l'approbation du marquage CE pour les ventes dans l'Union Européenne. Elle s'aligne également sur la révision du QMSR de la FDA, potentiellement facilitant la transition de Microbot vers cette réglementation mise à jour.
Microbot Medical Inc. (Nasdaq: MBOT), Entwickler des LIBERTY® endovaskulären robotischen chirurgischen Systems, hat die ISO 13485:2016-Zertifizierung für sein Qualitätsmanagementsystem erhalten. Diese Zertifizierung bestätigt das robuste Qualitätssystem des Unternehmens und zeigt die Einhaltung spezifischer Standards der Medizinbranche für Risikobewertung und Prozessmanagement in der regulierten Entwicklung und Herstellung medizinischer Produkte an.
Die ISO 13485-Zertifizierung wird als erster Schritt zur Einhaltung europäischer Vorschriften im Rahmen der neuen Medizinprodukteverordnung (EU MDR) angesehen und ist erforderlich für die CE-Kennzeichnung für den Verkauf in der Europäischen Union. Sie stimmt auch mit der überarbeiteten QMSR der FDA überein, was den Übergang von Microbot zu dieser aktualisierten Regelung potenziell erleichtern könnte.
- Received ISO 13485:2016 certification for quality management system
- Certification supports future regulatory submissions and commercialization efforts
- Aligns with FDA's revised QMSR, potentially streamlining regulatory compliance
- None.
Insights
The ISO 13485:2016 certification marks a significant milestone for Microbot Medical, validating their quality management system for medical device development. This certification is crucial for several reasons:
- It demonstrates the company's commitment to maintaining high-quality standards in product development and manufacturing.
- It's a prerequisite for CE marking, essential for entering the European market.
- It aligns with the FDA's recent QMSR revision, potentially streamlining future FDA submissions.
This certification positions Microbot Medical favorably for future regulatory approvals and commercialization efforts of their LIBERTY® Endovascular Robotic Surgical System. However, it's important to note that while this is a positive step, it doesn't guarantee product approval or market success.
Microbot Medical's ISO 13485 certification is a positive indicator for investors in the medical technology sector. It signifies the company's progress towards commercialization of its LIBERTY® system. Key points to consider:
- This certification can potentially accelerate regulatory approvals in various markets, including the EU and US.
- It may reduce regulatory risks and associated costs in the long term.
- The certification could enhance Microbot's attractiveness to potential partners or acquirers in the medical device industry.
However, investors should remain cautious. While this certification is important, it doesn't guarantee market success or profitability. The company still faces challenges in clinical validation, market adoption and competition in the robotics surgical space.
The ISO 13485 certification is a validation of the Company’s robust quality system
BRAINTREE, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces it has received ISO 13485:2016 certification for its quality management system. Receiving ISO 13485 certification indicates that a company has developed and implemented robust policies and procedures for the development and manufacture of regulated medical products.
The ISO 13485 standard was designed for the medical industry and requires a specific approach to risk assessment and the management of each process necessary for the development and realization of regulated medical products. Companies that comply with these quality requirements must prove that they consistently review and validate their product development and manufacturing processes, manage their operations with effective procedures, and maintain records for product traceability.
“I am extremely proud of the efforts by the entire Microbot team,” said Noa Ofer, PhD, Sr. Director of Quality Assurance and Regulatory Affairs. “An ISO 13485 audit is a very extensive process, and our certification is a testament that we are building the right capabilities and infrastructure as we progress toward commercialization.”
Compliance with ISO 13485 is often viewed as the initial step in ensuring adherence to European regulatory requirements under the new Medical Device Regulation (EU MDR) and is required to obtain CE mark approval for sales in the European Union. In addition, in view of the recent revision published by the FDA regarding the QMSR (quality system management regulation) and its incorporation by reference of the ISO 13485 standard, this certificate helps streamline Microbot’s transition into this revised FDA regulation.
About Microbot Medical
Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body.
The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.
Further information about Microbot Medical is available at http://www.microbotmedical.com.
Safe Harbor
Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Investor Contact:
Michal Efraty
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