Course Overview

This two-day course equips participants with the practical skills needed to plan, conduct, and report internal audits of a medical device QMS against ISO 13485:2016. The regulatory-driven nature of MedTech audits requires specialized technique – the course combines ISO 19011:2018 audit principles with the precision regulators expect when auditing design controls, CAPA, validation, traceability, and post-market processes.

Who Should Attend

• RA/QA staff in MedTech companies
• Internal auditors in device manufacturers
• Supplier-quality professionals serving MedTech
• MedTech project leads

What You Will Learn

• Plan and conduct internal ISO 13485:2016 audits in accordance with ISO 19011 principles
• Audit design controls, CAPA, validation, and traceability
• Link findings to FDA, EU MDR, and global regulatory expectations
• Document audit reports and verify corrective actions
• Apply the roles and responsibilities of an internal MedTech QMS auditor
• Support continual improvement of the medical device QMS

Course Content

• ISO 13485:2016 and MedTech regulatory refresher
• MedTech QMS audit programme and audit plan
• Auditing design controls and risk management
• Auditing CAPA, validation, traceability, and post-market processes
• Audit reporting, nonconformity writing, and corrective actions
• Practical exercises with MedTech audit case studies

Methodology

A blend of trainer-led sessions, group work, role-play audits, and case-based discussion. Participants conduct simulated audits drawn from device-manufacturing scenarios.

Assessment

Continuous assessment through case studies and exercises, complemented by a written end-of-course assessment.

Certificate

Prerequisites