ISO 13485: MEDICAL DEVICES QMS

ISO 13485 documents the minimum requirements for a Quality Management System (QMS) in Medical Device Industry in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, servicing or provision of associated activities (e.g. technical support).

ISO 13485 standard demonstrates that your medical device business is managed efficiently and responsibly with the benefits of stability and professionalism which that brings.

ISO 13485 is a globally recognised quality management system standard. These days and regarding importance of regulatory requirements in medical device industry, more and more businesses will only deal with accredited companies as they recognise the controls in product, service and quality.