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Learning Objectives

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

Why should you attend?

ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a 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.

After completing this course, you can sit for the exam and apply for the “PECB Certified ISO 13485 Foundation” credential. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.

Who Should Attend?

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

Course Overview

The “PECB Certified ISO 13485 Foundation” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competency domains:

Introduction to MDQMS concepts as required by ISO 13485
MDQMS requirements
Certification Exam

This course is expected to take an estimated 2 days, including examination day, to complete.

Upon the successful completion of the exam, you can apply for the credential “PECB Certified ISO 13485 Foundation”. For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.

For more information about exam details, please visit Examination Rules and Policies.

General Information

Certification and examination fees are included in the price of the training course
Training material containing over 200 pages of information and practical examples will be distributed
A participation certificate of 14 CPD (Continuing Professional Development) credits will be issued
In case of exam failure, you can retake the exam within 12 months for free

Registration Options

ISO 13485 Foundations - Self Study ($500.00)
Self Study Online PECB ISO 13485 Foundations

ISO 13485 Foundations Exam

ISO 13485 Foundations Study Materials

Materials released to student within 2 business days.

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