ISO 13485 Foundation Medical Devices (QMS) Training & Certification

Build a strong foundation in medical device quality management with the PECB ISO 13485 Foundation training course. This internationally recognized certification introduces the principles, concepts, and requirements of a Medical Devices Quality Management System (MDQMS) based on the ISO 13485 standard.

Designed for professionals new to medical device quality management, this course explains how organizations establish, implement, maintain, and continually improve Quality Management Systems that support the design, manufacture, installation, and servicing of medical devices while meeting regulatory and customer requirements.

After successfully passing the certification exam, you'll be eligible to apply for the PECB Certificate Holder in ISO 13485 Foundation credential, demonstrating your understanding of ISO 13485 requirements and Medical Device Quality Management System fundamentals.

Who Should Attend?

This course is ideal for:

• Professionals involved in medical device quality management
• Individuals seeking a foundational understanding of Medical Devices Quality Management Systems (MDQMS)
• Quality assurance and quality control professionals
• Regulatory affairs professionals
• Medical device manufacturers and suppliers
• Individuals pursuing a career in medical device quality management

Learning Objectives

By completing this course, you will be able to:

• Understand the principles and structure of a Medical Devices Quality Management System
• Explain the requirements of ISO 13485
• Understand the relationship between ISO 13485 and other management system standards and regulatory frameworks
• Learn the methods and techniques used to implement and manage an MDQMS
• Recognize the importance of continual improvement within a Quality Management System
• Prepare for the PECB ISO 13485 Foundation certification exam

Course Overview

This two-day training provides a practical introduction to ISO 13485 and Medical Device Quality Management Systems.

Participants will learn about:

• ISO 13485 fundamentals
• Medical device quality management principles
• Quality policies and objectives
• Operational controls
• Performance measurement
• Internal audits
• Management review
• Continual improvement
• Regulatory compliance
• Risk-based quality management

Interactive discussions, practical examples, and knowledge checks help reinforce learning while preparing participants for the certification examination.

Educational Approach

The course combines theory with practical learning activities.

Training includes:

• Instructor-led lectures
• Practical examples
• Interactive discussions
• Knowledge checks
• Practice examination questions similar to the certification exam

Prerequisites

There are no prerequisites for this course.

No previous experience with ISO 13485 or Medical Device Quality Management Systems is required.

Course Agenda

Day 1

Introduction to Medical Devices Quality Management System (MDQMS) concepts based on ISO 13485

Day 2

Medical Devices Quality Management System requirements and PECB Certification Examination

Certification Exam

The PECB ISO 13485 Foundation examination fully satisfies the requirements of the PECB Examination and Certificate Programme.

The examination evaluates two competency domains:

• Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
• Domain 2: Medical Devices Quality Management System (MDQMS) requirements

After successfully passing the examination, candidates may apply for the PECB Certificate Holder in ISO 13485 Foundation credential.

PECB Certification Requirements

What's Included

Your enrollment includes:

• Official PECB ISO 13485 Foundation training
• Certification examination
• Examination fees
• Official PECB training materials (200+ pages)
• Practical examples and exercises
• Certificate of Course Completion
• 14 Continuing Professional Development (CPD) credits
• One free exam retake within 12 months if needed

Available Training Format

Self-Study

Study at your own pace using official PECB learning materials and practical exercises.

The self-study format includes:

• Official training manual
• Practical examples
• Knowledge quizzes
• Practice examination questions
• Standard documentation
• Flexible online learning

Ideal for professionals preparing for certification while balancing work and personal commitments.

Why Choose PECB ISO 13485 Foundation?

ISO 13485 is the internationally recognized standard for Medical Device Quality Management Systems. It helps medical device manufacturers and suppliers consistently meet customer expectations, regulatory requirements, and quality objectives throughout the product lifecycle.

The PECB ISO 13485 Foundation course provides an excellent starting point for professionals entering the medical device industry or preparing to pursue advanced certifications such as ISO 13485 Lead Implementer or ISO 13485 Lead Auditor. Whether you're beginning a career in quality management, regulatory affairs, or medical device manufacturing, this certification demonstrates your understanding of internationally recognized quality management best practices.