ENDRA Life Sciences Achieves ISO 13485 Recertification

ENDRA Life Sciences Inc. has achieved 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. 
 
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. 

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS), a 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 currently in use globally. TAEUS is initially focused on measuring liver fat as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), chronic liver conditions that affect more than 1 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.