ISO 13485 Foundation Training

Live Online & Classroom Enterprise Certification Training

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.

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What is ISO 13485 Foundation Certification Training about?

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 Certified ISO 13485 Foundation” credential. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.

What are the objectives of ISO 13485 Foundation Certification Training ?

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

Who is ISO 13485 Foundation Certification Training for?

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

What are the prerequisites for ISO 13485 Foundation Certification Training?

There is no prerequisite to attend this course.

Available Training Modes

Live Online Training

12 Hours

Classroom Training

2 Days

Course Outline Expand All

Expand All

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 Certification Exam

Who is the instructor for this training?

The Trainer is PECB certified Instructor with extensive domain experience, including years of experience training & mentoring professionals in the industry.

ISO 13485 Foundation Certification Training - Certification & Exam

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

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Domain 2: Medical Devices Quality Management System (MDQMS)

For any queries; feel free to reach us at pecb@springpeople.com.

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