ISO 13485:2016 Medical Device Internal Auditor Training

ISO 13485:2016 Medical Device Internal Auditor Training udemy course free download

ISO13485:2016 Training

The ISO 13485:2016 Medical Device Internal Auditor Training course is designed to provide participants with the knowledge and skills required to conduct effective internal audits of a Quality Management System (QMS) in compliance with ISO 13485:2016. This training ensures that medical device organizations meet regulatory and customer requirements while maintaining a strong focus on product quality and patient safety.

Through a combination of theoretical instruction, real-world case studies, and hands-on exercises, learners will develop expertise in audit planning, execution, reporting, and follow-up actions. The course follows the principles of ISO 19011: Guidelines for Auditing Management Systems and emphasizes risk-based thinking, process auditing, and regulatory compliance.

This training is ideal for professionals working in quality assurance, regulatory affairs, manufacturing, and compliance roles, helping them enhance their ability to evaluate, improve, and maintain ISO 13485-compliant QMS processes.

Who Should Take This Course?

This course is designed for:
- Quality Assurance (QA) & Regulatory Affairs (RA) Professionals
- Internal Auditors & Compliance Officers
- Medical Device Manufacturers & Suppliers
- Production & Operations Managers
- Engineers & R&D Professionals
- Consultants & Regulatory Specialists
- Anyone involved in ISO 13485 compliance & QMS auditing

No prior auditing experience is required, but a basic understanding of ISO 13485:2016 is beneficial.

Course Format

Delivery Mode: Online / Self-Paced
Duration: 2–3 Days (Flexible Learning Options Available)
Training Materials: Course slides, audit templates