Dublin based startup Blafar secures ISO 13485:2016 certification

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

The secured ISO 13485:2016 certification is from a 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 the 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. 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. We are also actively seeking to collaborate with industry partners to accelerate the commercialisation of novel therapeutic products using our biopolymer platform technologies.”

blafar.com