CQI/IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements
September 19 – 23, 2022
This course consists of 5 days instruction followed by a 2-hour exam on the 6th day. Students will plan, conduct, report, and follow-up on a QMS audit in accordance with ISO 13485:2016, MDSAP, and EU MDR requirements. Throughout the course, students will learn how to apply MDSAP auditing strategies, adopted by Auditing Organizations in the MDSAP program, and learn to identify and grade nonconformities and prepare an audit report in accordance with MDSAP criteria. This course is currently certified to include ISO 13485:2016 and MDSAP requirements. Inclusion of EU MDR requirements in the accreditation is pending.
Who Should attend
This class is helpful for all management and executive personnel with responsibility for medical device regulatory lifecycles, involvement with the design and implementation of quality management systems or involvement with product design and development.