Bridge to Life Achieves ISO 13485:2016 Certification, Reinforcing Commitment to Quality and Safety in Hypothermic Oxygenated Perfusion and Cold Flush Organ Preservation Solutions
CHICAGO, Feb. 5, 2024 /PRNewswire/ -- Bridge to Life Ltd, a renowned market leader in cold flush organ preservation solutions, is proud to announce its recent certification for ISO 13485:2016. This achievement further solidifies the company's commitment to maintaining exceptional standards of quality and safety in its premier products, including Belzer UW, EasiSlush® and VitaSmart™1 Machine Perfusion System (Europe).
The company's decision to pursue formal certification through its European Notified Body was a strategic move in preparation for its highly anticipated US VitaSmart1 Machine Perfusion System launch (pending FDA approval). By obtaining this certification, Bridge to Life continues to demonstrate its unwavering commitment to meeting and exceeding these standards. As market leader for hypothermic oxygenated liver perfusion in Europe, Bridge to Life has been an FDA-registered company for over a decade.
"We are thrilled to have achieved ISO 13485:2016 certification" said Don Webber, CEO of Bridge to Life. "This accomplishment is a testament to our team's dedication to providing the highest quality products and services to our customers across the global markets we currently serve."
The International Organization for Standardization (ISO) is an independent, non-governmental international 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 the requirements for standardization and quality assurance.
Bridge to Life's ISO 13485:2016 certification serves as a testament to the company's continuous efforts to enhance its quality management systems and ensure the utmost safety and efficacy of its products. By adhering to these stringent standards, Bridge to Life aims to instill confidence in its customers, partners, and stakeholders, further solidifying its position as a trusted industry leader.
About Bridge to Life Ltd
Bridge to Life Ltd is a market leader in organ preservation, offering premier 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 (OPO) globally.
1 VitaSmart is CE Marked and available for sale in several markets outside of the United States. VitaSmart is not approved for sale in the US. The company successfully completed enrollment in its pivotal, multicenter, randomized clinical study in the US in 2023 and expects to submit its Premarket Approval submission to FDA later this year.
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