The ISO 13485 Lead Auditor Course is designed to develop the competence required to plan, lead, and conduct external or internal audits of Medical Devices Quality Management Systems (MDQMS) in accordance with ISO 13485:2016.

This intensive and practical course provides a deep understanding of ISO 13485 requirements, audit principles, and techniques in line with ISO 19011 and ISO/IEC 17021-1.

Participants will gain the expertise to lead audit teams, assess the effectiveness of medical device quality management systems, identify nonconformities, and support regulatory compliance and continual improvement within medical device organizations.