ENDRA Life Sciences Achieves Key Quality Management System Certification
March 31 2022 - 8:00AM
Business Wire
ISO 13485
Recertification Affirms Quality Standards Supporting ENDRA’s CE
Mark
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo
Acoustic Enhanced UltraSound (TAEUS®), announces receipt of Medical
Device Quality Management System ISO 13485:2016 and EN ISO
13485:2016 recertification, under Certificate Number MD 697226 from
the British Standards Institution (BSI). This recertification
affirms the company's Quality Management System (QMS) meets all
current regulatory requirements specific to the medical device
industry. The U.S. Food and Drug Administration (FDA) has proposed
adopting the ISO 13485:2016 standard, in an effort to harmonize the
FDA Quality System Regulation, 21 CFR 820, with the international
standard.
''This ISO 13485:2016 recertification validates the foundation
and sustainability of our QMS, upon which we obtained CE Marking.
It further demonstrates the commitment of our global
cross-functional team to uphold the highest quality product
development and manufacture of our TAEUS System to meet customer
and international regulatory standards,'' stated Amy Sitzler,
ENDRA’s Vice President of Engineering. “This designation is
testament to our commitment to quality as we advance our strategy
to develop optimized hybrid ultrasound and thermoacoustic imaging
systems, with our proprietary TAEUS technology in areas with unmet
clinical needs.''
The ISO 13485:2016 certification is an internationally
recognized standard for the medical device industry and establishes
the requirements for a comprehensive system, covering the design,
manufacture and distribution of medical devices. ENDRA's ISO
13485:2016 certification scope includes the design, development,
manufacture, service, installation and distribution of thermo
acoustic enhanced ultrasound medical devices and accessories.
About ISO
The International Organization for Standardization (ISO) is the
world's largest developer and publisher of international standards
for the implementation of quality management systems. The ISO
quality management standard embodies the requirements for a
comprehensive management system for the design and manufacture of
medical devices. ISO is a global network of national standards
bodies and its members are the foremost standards organizations in
their respective countries. Each member represents its country in
ISO. BSI, the United Kingdom's representative, is a full ISO member
(member body) that influences ISO standards development and
strategy by participating and voting in ISO technical and policy
meetings. Full members sell and adopt ISO international standards
nationally. For more information, please click here.
About British Standards Institution (BSI)
BSI (British Standards Institution) equips businesses with the
necessary solutions to turn standards of best practice into habits
of excellence. From assessment, certification and training to
software solutions, advisory services and supply chain
intelligence, BSI provides the full solution to facilitate business
improvement and help clients drive performance, manage risk and
grow sustainably. Through the passion and expertise of our people,
BSI embeds excellence in organizations across the globe to improve
business performance and resilience. BSI's influence spans across
multiple sectors with particular focus on Aerospace, Automotive,
Built Environment, Food, Retail, Healthcare and IT. For more
information, please click here.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced
UltraSound (TAEUS®), a ground-breaking technology being developed
to visualize tissue like MRI, but at 1/50th the cost and at the
point of patient care. TAEUS® is designed to work in concert with
400,000 cart-based ultrasound systems in use globally today. TAEUS®
is initially focused on the measurement of fat in the liver as a
means to assess and monitor Non-Alcoholic Fatty Liver Disease
(NAFLD) and Non-Alcoholic Steatohepatitis (NASH), chronic liver
conditions that affect over one billion people globally, and for
which there are no practical diagnostic tools. Beyond the liver,
ENDRA is exploring several other clinical applications of TAEUS®,
including visualization of tissue temperature during energy-based
surgical procedures. For more information, please visit
www.endrainc.com.
Forward-Looking Statements
All statements in this news release that are not based on
historical fact are "forward-looking statements" within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements, which
are based on certain assumptions and describe our future plans,
strategies and expectations, can generally be identified by the use
of terms such as “approximate,” "anticipate," “attempt,” "believe,"
"could," "estimate," "expect," “future,” "goal," "intend," "may,"
"plan," “possible,” “potential,” "seek," "should," "will," or other
comparable terms (including the negative of any of the foregoing),
although some forward-looking statements are expressed differently.
Examples of forward-looking statements for ENDRA include, among
others, estimates of the timing of future events and anticipated
results of our development efforts, including the timing for
receipt of required regulatory approvals and product launches,
expectations concerning ENDRA's business strategy, ENDRA’s ability
to find and maintain development partners, market acceptance of its
technology and the amount and nature of competition in its
industry, and its ability to protect its intellectual property.
Forward-looking statements involve inherent risks and uncertainties
that could cause actual results to differ materially from those in
the forward-looking statements as a result of various factors
including, among others, ENDRA’s ability to develop a commercially
feasible technology and its dependence on third parties to design
and manufacture its products; receipt of necessary regulatory
approvals; the impact of COVID-19 on ENDRA’s business plans;
ENDRA’s ability to find and maintain development partners, market
acceptance of ENDRA’s technology and the amount and nature of
competition in its industry; ENDRA’s ability to protect its
intellectual property; and the other risks and uncertainties
described in the Risk Factors and Management’s Discussion and
Analysis of Financial Condition and Results of Operations sections
of the Company’s most recent Annual Report on Form 10-K and in
subsequently filed Quarterly Reports on Form 10-Q filed with the
Securities and Exchange Commission. You should not rely upon
forward-looking statements as predictions of future events. The
forward-looking statements made in this news release speak only as
of the date of issuance, and ENDRA assumes no obligation to update
any such forward-looking statements to reflect actual results or
changes in expectations, except as otherwise required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220330005613/en/
Company Contact: Irina Pestrikova Senior Director,
Finance investors@endrainc.com www.endrainc.com
Investor Relations Contact: Yvonne Briggs LHA Investor
Relations (310) 691-7100 ybriggs@lhai.com
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