Jellagen Pty Ltd Receives ISO 13485:2016 Certification
Jellagen Pty Ltd is pleased to announce that the Welsh based marine biotechnology company has been certified to ISO 13485:2016 by leading Certification Body – LRQA, for the manufacture of medical grade next generation collagen derived from jellyfish.
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This achievement now enables Jellagen to manufacture medical grade jellyfish collagen biomaterials for the medical device market and provides Jellagen a platform, from which to further enhance the company’s Quality Management System (QMS) for the development of our own medical devices for wound and regenerative medicine applications.
Dr Andrew Mearns Spragg, the Company’s Founder and Chief Executive Officer said “We’re delighted that our Quality Management System (QMS) has met the requirements for ISO 13485:2016. I would like to congratulate the Jellagen team for their hard work, and in particular thank Mr Alex Picton, Jellagen’s Operations Manager and Mr Henry Sibun of Henry Sibun Associates Ltd for their extremely hard work developing and implementing Jellagen’s Quality Management System. Achieving ISO 13485:2016 has been a core business objective for the Company and I am immensely proud of the team’s efforts in achieving this goal.”
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