Fleming Medical Ltd, one of Ireland’s leading pharmaceutical and medical distributors, supplying high quality healthcare diagnostic equipment and medical consumables, has successfully achieved ISO 13485 certification to the internationally recognised Standard for Medical Devices Quality Management Systems
Fleming Medical was established in 1986 and is a fully Irish owned company employing a workforce in excess of forty employees. The company distributes both own-brand (private label) and supplier branded products. The company operates in a regulated environment and is already certified to the International quality management system standard ISO 9001.
In January 2009 Fleming Medical made the decision to pursue certification to ISO 13485. Almir Business was selected as the preferred consultancy practice to help Fleming Medical establish and implement the ISO 1345 Medical Devices Quality Management System. In March, 2009 Fleming Medical aggressively started pursuing certification, achieving its goal to be certified in July, 2009.
Commenting on the award, Human Resources Manager and Quality Management Representative, Adrienne McCarthy, said “We are pleased to receive the ISO13485 certification which is critical to growing and developing our business. This standard is vital to our business as it enables us to CE mark our own products and continue our efforts in developing our own branded medical consumables and diagnostic equipment product portfolio. We sell these products to the professional healthcare markets and this standard means that our systems are under continual scrutiny to ensure we are consistently providing the highest level of product quality and excellent service to customers”.
[intlink type=”p” slug=”medical-devices-iso-13485″ text=”ISO 13485″] is the international gold standard for companies involved in the manufacture of medical devices. Recognised throughout the world, ISO 13485 certification is evidence of a company’s commitment to its customers through the high quality of its products and services. It demonstrates the existence of a highly effective quality management system which meets international regulatory, safety and quality concerns specific to the medical device industry.
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