ISO 13485 Foundation Training

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

After completing this course, you can take the exam and apply for the “PECB Certified ISO 13485 Foundation” credential. The 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.

Professionals 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. 

Lecture sessions are illustrated with practical questions and examples.

Practical exercises include examples and discussions.

Practice tests are similar to the Certification Exam.


Other details


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