November 6 – 10, 2023
This course consists of five days of instruction followed by a comprehensive written (two-hour exam) on the sixth business day. Learners will plan, conduct, report, and follow up on a QMS audit in accordance with ISO 13485:2016, MDSAP, and EU MDR requirements. Learn how to apply the MDSAP Audit Approach adopted by Auditing Organizations in the MDSAP program, to identify and grade nonconformities and prepare an audit report in accordance with MDSAP criteria.
This CQI and IRCA medical device lead auditor certified course is currently certified to include ISO 13485:2016 and MDSAP requirements.
Who Should Attend
This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.