30th November 2023

Arterius Ltd receives ISO 13485 Certification

BQAI Certification
BQAI Certification
Date: 30th November 2023

Arterius Limited, a Leeds-based, UK company developing innovative medical devices with a focus on next generation bioresorbable peripheral stents and drug coated balloons, has announced that on 17th November 2023 it has obtained EN ISO 13485:2016 certification for its Quality Management System, following a successful audit by BQAI (Ireland).

The scope of the certification is:
Design, development, pre-clinical and clinical evaluation of bioresorbable drug-eluting stents (scaffolds), drug-coated balloons intended to treat vascular disease, and related technologies such as coating and material enhancement.

ISO 13485 is the internationally accepted standard a medical device organisation can implement to demonstrate compliance with MedTech legislations.

Nial Bullett, Arterius’ Operations Manager, commented:
“Obtaining ISO 13485 Certification for our Arterius QMS will ensure recognition for Arterius’ compliance with ISO 13485 requirements and demonstrate confidence in our consistent design and development of our innovative medical device development products”.
Kadem Al-Lamee, Chief Technical Officer of Arterius, commented:
“Achieving this ISO 13485 certification gives confidence to our investors and stakeholders that we are committed to ensuring excellent product design and development of our products and, ultimately, ensuring patient safety”.

For further information

Arterius Ltd.

Kadem Al-Lamee, CTO

+44(0) 113 426 4300