This course develops competency in quality management systems auditing for medical devices, aligning with ISO 13485 and global regulatory expectations. Covers ISO 13485 requirements in detail and audit techniques (planning, conducting, reporting audits) to evaluate manufacturer compliance .

The course will be of value to quality and regulatory professionals involved in medical device QMS auditing (industry or regulators, globally).

Outcome: Trainees acquire certified lead auditor skills, enabling them to effectively audit and assess medical device manufacturers QMS for compliance with ISO 13485 and regulatory standards. This supports regulators in oversight of device manufacturing quality and conformity assessments

CDG is a private training entity – see https://www.cdgtraining.com/aboutus