General Overview

This course is intended to provide participants with a basic understanding of ISO 13485 requirements and how to interpret them, as well as the benefits of implementing a medical device quality management system.

Understanding ISO 13485 will benefit organizations that need to demonstrate that they can provide medical devices that consistently meet customer and regulatory requirements.

Participants will be able to understand the various modules of a quality management system, including QMS policy, procedures, performance measurements, management commitment, internal audit, management review, and continuous improvement, after completing this I-RAB Certified training course.

Who should attend?

• Top Management and executive management
• Technical experts designing, implementing, maintaining and/or improving a medical device
  seeking to understand Quality Management System. 
• Consultants interested in MD Quality Management System

Prerequisites

No prerequisite is required