AegirBio UK facility ISO 13485 compliant

We are pleased to announce that our product development site in the UK has been successfully, independently assessed and found to be compliant with ISO 13485:2016.

The ISO 13485 certification is an endorsement of the Quality Management System (QMS) that underpins the Company's position as a trusted manufacturer of medical devices. The accreditation is recognised on an international scale and is a critical part of gaining regulatory approval for our products. Moreover this development is important in enabling the Company to operate with greater capacity and improved efficiency and is a crucial step towards the development, manufacturing and distribution of our current products but also the ones included in our product pipeline portfolio.

AegirBio are committed to the continuous improvement of its functions and the services it provides, always keeping our customers’ needs at the forefront of the decisions we make.  This ISO certification is evidence of our commitment to the highest standards of product performance, quality, consistency, and reliability.