Course Overview

This comprehensive course is designed to provide participants with the practical knowledge and skills needed to document, implement, and maintain an effective Medical Device Quality Management System (MDQMS) in accordance with ISO 13485:2016 requirements.

Through structured modules and hands-on exercises, participants will learn how to develop mandatory documents, procedures, and records, as well as how to effectively implement, control, and improve the system within their organizations.

Duration

🕒 5 Days (Total: 40 Hours)

Course Objectives

By the end of this course, participants will be able to:
✅ Understand the structure and documentation requirements of ISO 13485:2016.
✅ Identify and develop mandatory documents and records for a compliant MDQMS.
✅ Design a practical implementation plan aligned with ISO 13485:2016 clauses.
✅ Apply risk-based thinking and regulatory requirements during implementation.
✅ Monitor and measure the effectiveness of QMS processes.
✅ Establish document control and version management systems.

Who Should Attend?

This course is ideal for:
✔ Quality and regulatory affairs professionals.
✔ QMS implementation team members.
✔ Medical device company managers and supervisors.
✔ Anyone responsible for developing or maintaining ISO 13485:2016 documentation.

Course Contents

📌 Introduction to ISO 13485:2016 – Overview of requirements and structure.
📌 Documentation Requirements – Mandatory documents, records, and their control.
📌 Process Mapping & Documentation – Defining, documenting, and controlling processes.
📌 Implementation Planning – Developing a step-by-step MDQMS implementation strategy.
📌 Risk Management Integration – Aligning risk control with ISO 14971 principles.
📌 Internal Control Mechanisms – Auditing, management review, and continual improvement tools.
📌 Document Control Procedures – Version control, distribution, and record retention.
📌 Practical Workshops & Knowledge Checks – Reinforcing concepts through real-world exercises.

Certification

🎓 Upon successful completion of the course, participants will receive an internationally recognized certificate from the RIMAN Training Center.