ISO 13485 Foundation

★★★★★ 4.5/5

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.

Training Options

Classroom Training

Online Instructor Led

Onsite Training

Course Information

Course Syllabus
Who It’s for
FAQs

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

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
An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
In case of exam failure, you can retake the exam within 12 months for free

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 Certification Exam

Audience Profile

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

100% Business Fulfilment

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Corporate Training Options

Online Instructor Led

Live, Online Training by top Instructors and practitioners across the globe.

Onsite
Training

Conduct training at the work location you desired.

Classroom Training

The Venue will be ideally located and easy to access with covid-19 SOP's.

Overseas Training

Travel to any desired location for your training.

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What People say?

Mohammed Aljbreen Operation Specialist, SAMA

The Clarity of the Content was very good. The explanation of the trainer with in-depth knowledge in a proper flow really impressed me to give 5 star rating.

Arindam Chakraborty Systems Specialist, King Abdullah University of Sciences & Technology

The Instructor was really impressive. Clear cut explanation of every topic he covered with real time scenarios.

Sher Afzal Khan Cloud Engineer, Cloud 9 Networks

The Trainer and the Course Material, both are good. Good flow of explanation with simple examples. The complete training was focused on current industry challenges.

Jawed Ahmad Siddiqui Sr. System Administrator, Saudi Ceramics

The Trainer’s presentation was impressed me to continue the course till end. Never feel bore till the entire sessions. She studied our mindset and follows.