Bridge to Life Achieves ISO 13485:2016 Certification, Reinforcing Commitment to Quality and Safety in Hypothermic Oxygenated Perfusion and Cold Flush Organ Preservation Solutions

"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."  "We are thrilled to have achieved ISO 13485:2016 certification" saidDon Webber, CEO of Bridge to Life. "This accomplishment is a testament to our team's dedication to providing the highest quality products and...

"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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