Course Overview

This awareness course provides participants with a fundamental understanding of the ISO 13485:2016 Quality Management System (QMS) for medical devices. The course outlines the importance of establishing a structured system to ensure product safety, regulatory compliance, and consistent quality throughout the medical device lifecycle.

Participants will gain insights into the structure, core principles, and key clauses of the ISO 13485:2016 standard, along with the benefits of implementing a certified QMS within medical device organizations.

Duration

🕒 2 Days (Total: 16 Hours)

Course Objectives

By the end of this course, participants will be able to:
✅ Understand the purpose and benefits of ISO 13485:2016 for medical device companies.
✅ Recognize how their role contributes to the effectiveness of a medical device QMS.
✅ Identify the structure and major requirements of ISO 13485:2016.
✅ Understand risk management principles in medical device production.
✅ Appreciate the implications of regulatory non-conformance.
✅ Support compliance and quality objectives in their daily operations.

Who Should Attend?

This course is ideal for:
✔ Employees at all levels in medical device companies.
✔ Quality, regulatory affairs, and production personnel.
✔ Maintenance, purchasing, and administrative staff involved in QMS operations.
✔ Individuals seeking awareness of ISO 13485:2016 requirements.

Course Contents

📌 Introduction to Medical Device Quality Management – Importance and objectives.
📌 Overview of ISO 13485:2016 – Standard purpose, scope, and benefits.
📌 Structure and Key Clauses – Main requirements and their intent.
📌 Risk Management and Product Safety – Managing hazards throughout the product lifecycle.
📌 Consequences of Non-Conformance – Legal, reputational, and operational risks.
📌 Interactive Activities & Knowledge Checks – Reinforcing key learnings in practice.

Certification

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