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.
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.
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.