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ISO 13485 Foundation
Duration
2 Days
Course
PECB-ISO13485FD
Available Formats
Classroom Training, Online Training
Course Description
Overview
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.
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
General Information:
- Certification and examination fees are included in the price of the training course.
- An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued.
- In case of exam failure, you can retake the exam within 12 months for free.
Objectives
By the end of this training course, students will be able to:
- 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
Audience
- 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
Topics
- 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
- Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Domain 2: Medical Devices Quality Management System (MDQMS)
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Self-Paced Training Info
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- Same in-demand topics as instructor-led public and private classes.
- Standalone learning or supplemental reinforcement.
- e-Learning content varies by course and technology.
- View the Self-Paced version of this outline and what is included in the SPVC course.
- Learn more about e-Learning
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Please take a moment to fill out this form. We will get back to you as soon as possible.
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