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-Bridge to Life achieves ISO 13485:2016 certification, reinforcing the commitment to quality and safety in organ preservation solutions through hypothermic oxygenated perfusion and cold lavage
CHICAGO, Feb. 5, 2024 /PRNewswire/ -- Bridge to Life Ltd, a recognized market leader in cold wash organ preservation solutions, is proud to announce its recent ISO 13485:2016 certification. This achievement further solidifies the company's commitment to maintaining exceptional standards of quality and safety across its core products, including Belzer UW, EasiSlush® and VitaSmart™1 Machine Perfusion System (Europe).
The company's decision to obtain formal certification through its European Notified Body was a strategic move in preparation for the highly anticipated launch of the VitaSmart1 machine infusion system in the US (pending FDA approval). By earning this certification, Bridge to Life continues to demonstrate its unwavering commitment to meeting and exceeding these standards. As the market leader in hypothermic oxygenated liver perfusion in Europe, Bridge to Life has been an FDA registered company for over a decade.
"We are delighted to have achieved ISO 13485:2016 certification," said Don Webber, CEO of Bridge to Life. "This achievement is a testament to our team's dedication to providing the highest quality products and services to our customers in all of the global markets we currently serve."
The International Organization for Standardization (ISO) is an independent international non-governmental organization that develops standards to ensure the quality, safety and efficiency of products, services and systems. ISO certification confirms that a management system, manufacturing process, service or documentation procedure has met all standardization and quality assurance requirements.
Bridge to Life's ISO 13485:2016 certification is a testament to the company's ongoing efforts to improve its quality management systems and ensure maximum safety and effectiveness of its products. By adhering to these strict standards, Bridge to Life aims to instill confidence in its clients, partners and stakeholders, further solidifying its position as a trusted industry leader.
Acerca de Bridge to Life Ltd
Bridge to Life Ltd is a market leader in organ preservation, offering premium products such as Belzer UW, EasiSlush and the VitaSmart1 machine perfusion system. With a strong focus on product quality, innovation and accessibility, the company serves and partners with leading transplant centers and organ procurement organizations (OPOs) globally.
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