This course covers medical device auditing, management systems auditing, and lead auditor requirements. Through simulation case study activities, participants apply and audit the requirements of ISO 13485 using auditing techniques as referenced by ISO 19011. The course is appropriate for ISO 13485 auditors, individuals responsible for planning and scheduling an ISO 13485 internal audit program, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel, and anyone desiring an in-depth understanding of the ISO 13485 Audit Process. It is available on-site at your organization.