ISO 13485 Foundation Certification Training Course Overview

ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.

Target Audience

  • Individuals involved in Medical Devices Quality Management
  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
  • Individuals interested to pursue a career in Medical Devices Quality Management

Learning Objective

  • Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand the approaches, methods and techniques used for the implementation and  management of a MDQMS

ISO 13485 Foundation (16 Hours) Download Course Contents

Live Virtual Classroom Fee On Request
Group Training
18 - 19 Oct 09:00 AM - 05:00 PM CST
(8 Hours/Day)

01 - 02 Nov 09:00 AM - 05:00 PM CST
(8 Hours/Day)

06 - 07 Dec 09:00 AM - 05:00 PM CST
(8 Hours/Day)

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

Start Time : At any time

12 AM
12 PM

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Course Prerequisites
  • Basic Computer Knowledge.