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.

Latest News

Our Sustainability Model

As a Med Tech company that aims to improve people’s health, we recognise the need to preserve a healthy environment. The link between human and environmental health is well established: the WHO states that one in four premature deaths is related to environmental issues caused by humans and the World Bank acknowledges that sustainable management…

Novel Collaboration between Zoan Biomed and University of Galway to Assess Laboratory Bone Formation

Zoan Biomed and the University of Galway to develop high throughput rapid assessment methods for biocompatibility and osteogenic potential of orthopaedic scaffold; reducing time to clinical data and developing a path to remove the need for animal testing.

Zoan Biomed featured in Bonezone

Zoan Biomed were delighted to be featured in the August edition of the leading orthopaedic industry magazine, Bonezone, a popular US publication covering the most prominent breakthroughs in Orthopaedics.

Northwell Health USA and Portershed Galway Visit Zoan

We were delighted to have the opportunity to host, Mary Rodgers (CEO, PorterShed Galway) ,
Kevin Beiner (Senior Vice President and Regional Executive Director, Northwell Health) Elaine
Brennan (Executive Director & Chief Commercialization Officer at Northwell Health) Jennifer
Scanlon (AVP Strategic Partnerships at Northwell Health) to our facility last week.

Contact Us

To find out more about Zoan BioMed get in touch