ISO 13485 Medical Devices Quality Management Systems
Course ID IS013485FE
Course Name ISO 13485 Foundation
Language English
Training Duration 2 Days
CPD Certification (Credits) 14 CPD
Exam Duration 1 hour
Retake Exam Yes
Course Outline Brochure
Embedded Files
Why should you attend?
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?
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 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
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
None
Course Agenda
Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
Day 2: Medical Devices Quality Management System requirements and Certificate Exam
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