This training focuses on the practical knowledge and skills required to plan, conduct, report and follow up audits of Medical Device Quality Management Systems against ISO 13485:2016.

Key Learning Areas

🔹 Medical Device QMS and applicable regulatory requirements
🔹 Auditor roles and responsibilities
🔹 Audit planning, conducting, reporting and follow-up
🔹 ISO 19011 and ISO/IEC 17021 principles
🔹 Relationship between ISO 13485 and medical device regulations
🔹 Risk management principles relevant to medical devices

A thoughtful next step for professionals who already understand medical device QMS and want to strengthen their auditing capability.