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

Who Should Attend?

This training course is intended for individuals involved in Medical Devices Quality Management; individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS); and individuals interested in pursuing a career in Medical Devices Quality Management.

Learning Objectives

Participants will 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; and understand the approaches, methods, and techniques used for the implementation and management of a MDQMS.

Educational Approach

Lecture sessions are illustrated with practical questions and examples. Practical exercises include examples and discussions. Practice tests are similar to the Certificate Exam.

Prerequisites

There are no prerequisites to participate in this training course.