Microbot Medical Receives Quality Certification to Support Future Regulatory Submissions and Commercialization
2024年8月13日 - 9:30PM
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
IR@microbotmedical.com
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