Endra Life Sciences Inc (NDRA)

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ENDRA Life Sciences Receives ISO 13485 Certification
ACCESSWIRE ACCESSWIREApril 3, 2019
ANN ARBOR, MI / ACCESSWIRE / April 3, 2019 / ENDRA Life Sciences Inc. (''ENDRA'') (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.

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 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") (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.