ANN ARBOR, MI / ACCESSWIRE / April 3, 2019 / ENDRA Life Sciences Inc. (”ENDRA”) (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, has received Medical Device Quality Management System ISO 13485:2016 and EN ISO 13485:2016 certification, under Certificate Number MD 697226 from British Standards Institution (BSI). This ISO certification indicates that the company’s Quality Management System (QMS) meets the most current regulatory requirements specific to the medical device industry.
The ISO 13485:2016 standard for medical devices establishes the requirements for a comprehensive system, covering the design, manufacture, and distribution of medical devices. ENDRA’s ISO 13485:2016 certification scope includes:
- Design, development, control of manufacture, service, installation and distribution of thermo-acoustic enhanced ultrasound medical devices and accessories.
This ISO 13485:2016 scope indicates that ENDRA has established the Quality Management System infrastructure necessary for it to complete the design and initiate commercialization of the ENDRA Life Sciences-patented Thermo Acoustic Enhanced Ultrasound (TAEUS) clinical technology, designed to aid clinicians in management of liver disease with fatty tissue characterization (pending product-specific CE-Marking).
”This certification represents an important milestone achievement towards our CE Mark as it demonstrates the commitment of our global cross-functional team to quality, and to meeting customer and international regulatory expectations,” said Amy Sitzler, ENDRA’s Vice President of Engineering and Programs. ”This ISO 13485 certification and scope verifies the Quality Management System designed to ensure the highest quality product development and manufacture of our TAEUS FLIP System. It is the culmination of a year’s work of development, implementation, training and refinement of nearly 50 core business processes,” concluded Sitzler.
The ISO 13485:2016 certification is an internationally recognized standard for the medical device industry. The U.S. Food and Drug Administration (FDA) recently announced its intention to adopt the ISO 13485:2016 standard, in an effort to harmonize the FDA Quality System Regulation, 21 CFR 820, with the international standard.
”A commitment to quality is central to our mission and we believe that achieving the British Standards Institute (BSI) ISO 13485:2016 certification validates our team’s capabilities and maturity in establishing ENDRA’s processes to develop and manufacture diagnostic products for medical use,” said ENDRA’s CEO Francois Michelon.
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 Institute (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 Inc. (“ENDRA”) (NASDAQ: NDRA) is a developer of enhanced ultrasound technologies. ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS™) platform to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only with CT & MRI – at a fraction of the cost, and at the point-of-care. ENDRA’s first TAEUS application will focus on the fatty liver tissue characterization, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease (NAFLD). ENDRA’s goal is to bring new capabilities to ultrasound – thereby broadening access to better healthcare. For more information, please visit www.endrainc.com.
About Non-Alcoholic Fatty Liver Disease (NAFLD)
NAFLD is a condition closely associated with obesity, diabetes, hepatitis-C and certain genetic predispositions in which fat accumulates in the liver. NAFLD affects over 1 billion people globally and is estimated to cost the U.S healthcare system over $100 billion annually. NAFLD is often asymptomatic and if left untreated, NAFLD can progress to inflammation (NASH), tissue scarring (fibrosis), cell death (cirrhosis) and liver cancer. By 2025, NAFLD is forecast to be the greatest root cause of liver transplants. The only tools currently available for diagnosing and monitoring NAFLD are impractical: expensive Magnetic Resonance Imaging (MRI) or an invasive surgical biopsy.
All statements in this 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 forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. Examples of forward-looking statements include, among others, statements we make regarding the results of pending human studies and nature of the data obtained from such studies; the adequacy of protections afforded to us by the patents that we own and the success we may have in, and the cost to us of, maintaining, enforcing and defending those patents; expectations concerning ENDRA’s ability to secure regulatory approvals; estimates of the timing of future events and achievements, including obtaining a CE Mark and commercializing the TAEUS device; and expectations concerning ENDRA’s business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; our ability to find and maintain development partners, market acceptance of our technology, the amount and nature of competition in our industry; our ability to protect our intellectual property; and the other risks and uncertainties described in ENDRA’s filings with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, 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.
SOURCE: ENDRA Life Sciences Inc.
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