PECB/ISO 13485 Lead Implementer

ISO 13485 Lead Implementer Certification Training Course Overview

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485.

Target Audience

  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members

Learning Objectives

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks 
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

ISO 13485 Lead Implementer (40 Hours) Download Course Contents

Live Virtual Classroom Fee For Both Group Training & 1-on-1 Training On Request
Group Training
08 - 12 Aug 09:00 AM - 05:00 PM CST
(8 Hours/Day)

06 - 10 Sep 09:00 AM - 05:00 PM CST
(8 Hours/Day)

1-on-1 Training (GTR)
4 Hours
8 Hours
Week Days
Week End

Start Time : At any time

12 AM
12 PM

GTR=Guaranteed to Run
Classroom Training (Available: London, Dubai, India, Sydney, Vancouver)
Duration : On Request
Fee : On Request
On Request
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Course Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.