Quality Management System

Blafar Ltd’s Quality Management System complies with the international standard ISO 13485:2016. This certification, awarded by Lloyd’s Register Quality Assurance Limited (LRQA), validates our commitment to designing, developing, manufacturing, and supplying superior functionalised biomaterials for R&D, medical devices, and medical technologies.

The scope of the certification is applicable to the ‘design, development, manufacture and supply of functionalised biomaterials for use in R&D, medical devices and medical technologies, including extracellular matrix-based biopolymers and synthetic biopolymers.

Quality policy

“Blafar Ltd is committed to the design, development, manufacture and delivery of superior quality biomaterials and services for R&D and medical technology applications that lead Blafar Ltd to be the preferred supplier of the biopolymer products and solutions we offer.

To provide products that respond to the needs of our customers, Blafar Ltd is dedicated to encouraging innovation, fostering successful academic and industrial partnerships, using motivated, qualified staff, and implementing and maintaining an effective Quality Management System throughout the organisation, which was developed in compliance with international regulatory requirements, including, but not limited to, ISO13485: 2016 and US FDA 21 CFR Part 820 Quality System Regulation.

Blafar Ltd shall communicate this Quality Policy, and the organisational objectives required to achieve this policy, throughout the organisation so that employees can understand and strive to fulfil the requisite commitments.”

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