The ISO 13485 standard, currently ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device. Certification demonstrates your commitment to meeting your customers’ requirements and supports regulatory compliance in many jurisdictions.
Our wide range of regulatory approvals, our United Kingdom Accreditation Service (UKAS) accreditation and close links with medical authorities enable us to meet your certification requirements effectively. For many markets, ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices. With a strong reputation for certification, we have the expert knowledge and global networks of auditors to help you achieve your objectives.