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.