Zoan Biomed awarded ISO 13485:2016 certification for the Design, Development and Manufacture of Bone Graft Substitutes

team outside with view cert

December 2021,
Zoan Biomed was awarded it’s ISO 13485:2016 certification – the international standard for quality management systems in the medical device industry. This is a fundamental step ahead of market approval and registration of our Zoan G03 product in the US and Europe.

This is the outcome of a multi year effort that has taken our innovative, sustainable and natural solution and translated that into an internationally recognised platform that is ready for manufacturing and human use.

James Martin, Production Director and Flora Joyce, Scientific Officer & QA Lead led the initiation, development, and execution of the Quality Management System supported by the day-to-day expertise of Michael O’Donnell and Rose Mongan.

It gives the company a substantial foundation now to meet the requirements of customers, ensure compliance with regulation and drive excellence in the day-to-day operating practices. Most importantly it is a key step in delivering on our key principle of patient safety

Zoan Biomed has completed its most recent 12 month GLP pre-clinical trial which delivered further exciting results on our materials ability to heal bone and provide outstanding structural stability, while being biocompatible and bioresorbable.

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Kevin Beiner (Senior Vice President and Regional Executive Director, Northwell Health) Elaine
Brennan (Executive Director & Chief Commercialization Officer at Northwell Health) Jennifer
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Dublin, Boston, Gothenburg – April, 2022—Imagine a future where a bone break can be repaired by 3D-printing bones made from marine coral. That reality may come a lot sooner that one might think, thanks to a truly innovative collaboration agreement between Irish-owned, and Galway-based, Zoan BioMed, and Sweden-based CELLINK (STO: BICO). Uniquely, Zoan BioMed sustainably grows…

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