Blafar Secures Medical Device Industry Quality Management System Standard Certification

Blafar Secures Medical Device Industry Quality Management System Standard Certification

Blafar Ltd, which develops functionalised biopolymers, novel bio-compatible injectable hydrogels with multiple bio-applications, as well as bio-inks for 3D printing, today announced that it has secured an internationally recognised quality management system standard certification specific to the medical device industry.

Blafar has secured the ISO 13485:2016 certification from the renowned notification body Lloyd's Register Quality Assurance Ltd (LRQA) for its Quality Management System (QMS).

The company, founded in 2018 by Professor Wenxin Wang, is headquartered at NovaUCD, the Centre for New Ventures and Entrepreneurs at University College Dublin (UCD).

Blafar develops and commercialises a range of biomaterial products from multifunctional extracellular matrix (ECM) based and synthetic biopolymers for injectable hydrogel formation and the delivery of stem cells and drugs, with applications in the health, life science and research sectors, as well as bio-inks for 3D printing.

Health related applications include tissue engineering and regeneration, such as wound healing, cartilage and bone repair, stem cell delivery and drug delivery, as well as medical aesthetic applications such as dermal fillers.

Dr Hongyun Tai, CEO of Blafar said, “Securing this international certification is a significant achievement for the company and demonstrates our commitment to provide functionalised biopolymer products of superb quality to our customers around the world.”

She added, “By developing high-quality and novel formulations containing unique functionalised biopolymers products, Blafar’s ambition is to be a leader in the global consumer market of multifunctional biopolymer products with applications in fields such as tissue engineering, medical aesthetic and cosmetics.”

She concluded, “We are also actively seeking to collaborate with industry partners to accelerate the commercialisation of novel therapeutic products using our biopolymer platform technologies.”


11 August 2020

For further information contact Micéal Whelan, Communications and Media Relations Manager, UCD Research and Innovation, NovaUCD, e:, or Dr Hongyun Tai, Blafar, e:

Editors Notes

Blafar’s goal is to become a leader in the global consumer market of biopolymers for regenerative medicine and tissue engineering applications.

The scope of Blafar’s ISO 13485:2016 certification from LRQA is applicable to  ‘Design, develop, manufacture and supply of functionalised biomaterials for use in R&D, medical devices and medical technologies, including extracellular matrix-based biopolymers and synthetic biopolymers.’

At NovaUCD, the hub for new ventures and entrepreneurs at University College Dublin, we nurture and support new high-tech companies as part of UCD's mission. At NovaUCD we provide purpose-built, state-of-the-art incubation facilities alongside a comprehensive business support programme for client companies such as Blafar. NovaUCD has been funded through a unique public-private partnership that includes AIB Bank, Arthur Cox, Deloitte, Enterprise Ireland, Ericsson, Goodbody Stockbrokers, UCD and Xilinx.