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).

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”.

Arterius Ltd receives ISO 13485 Certification

Arterius Limited
Mayesbrook House
Lawnswood Business Park
Redvers Close
Leeds
LS16 6QY

Homepage

Home

Technology

About

About us

Team

Newspage

News

Publications

Contact

Contact us

Technologies

Arterius CTO, Dr Kadem Al-Lamee, will present on Arterius' approach to drug-coated balloons for use to treat peripheral arterial disease at the 4th International Conference on Biomaterials & Biodevices in Rome, Italy, November 16–17 2023. Details for the conference are available 

Arterius to present at BioMat 2023

Arterius CTO, Dr Kadem Al-Lamee, presented on the company's bioresorbable scaffold technology at the Annual World Congress of Smart Materials, 22–24 July 2023 in Barcelona, Spain. Further details on the conference are available at 

Arterius presents at World Congress of Smart Materials 2023

Arterius to present a poster at the Charing X International Symposium in London, 25–27 April 2023 entitled 'Development of Innovative Bioresorbable Stents to Treat Patients with Critical Limb Ischaemia in Below-the-Knee Peripheral Artery Disease'. The poster chatacterises Arterius' bioresorbable scaffold and is available to download. 

Arterius poster presented at Charing X International Symposium 2023

Arterius Limited, a Leeds UK-based company developing innovative medical devices with a focus on next generation bioresorbable peripheral stents and drug coated balloons, has announced that it has appointed Gerard Harper as Chief Financial Officer. In this role, Gerard will help Arterius to develop and drive the commercial strategy for the successful launch of a suite of innovative technologies in its current pipeline.

Gerard brings extensive experience in medical devices and healthcare companies gained through roles in investment banking, venture capital and early-stage companies. Gerard held finance and commercial roles at Quanta Dialysis Technologies for over six years helping to guide its development into one of the most prominent emerging
medical device companies in the UK.

Gerard will build on the success of Kadem Al-Lamee, co-founder and Chief Technical Officer who is leading the development of the existing product pipeline and IP and of new applications and technologies.

“I want to welcome Gerard to Arterius as he brings a wealth of leadership experience in commercial development and investment in life sciences. His track record will be invaluable as Arterius continues its journey through the development of innovative technologies in the MedTech sector.”

“I am delighted to join Arterius at this exciting time as it aims to bring two class-leading product platforms to market, with the capability to transform the management of peripheral arterial disease”.

To learn more visit: www.arterius.co.uk





Arterius Ltd receives ISO 13485 Certification

More news stories