This course is tailored for professionals working in the medical device industry who are responsible for conducting internal audits of Quality Management Systems in compliance with ISO 13485:2016. It provides essential auditing skills, deepens understanding of regulatory requirements, and ensures alignment with international standards for medical device manufacturing and services.

Package for Delegates

• ISO 13485:2016 Reference Materials
• Internal Audit Checklist Templates
• Real-world Case Studies & Audit Scenarios
• Lunch & Refreshments (In-person only)
• Access to Mock Exams & Role-playing Sessions
• Certificate of Completion

Examination

A short theory-based test and a practical audit exercise will be conducted at the end of the course. Successful candidates will receive an ISO 13485:2016 Internal Auditor Certificate, demonstrating competency in auditing medical device QMS.

Accreditation

Delivered by trainers from IRCA-recognized training providers and aligned with the auditing practices under ISO 19011. This certification is recognized globally in the medical device sector.

Variety of Jobs with this Course

Completion of this course opens doors to roles such as:

• Internal Auditor – Medical Devices
• Quality Assurance Specialist
• Regulatory Compliance Officer
• Quality Management System (QMS) Coordinator
• Medical Device Compliance Auditor
• Supplier Quality Engineer