ISO 13485 Foundation (QMS) Training & Certification
Regular price
$495.00
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
Credential
Exam
Professional Experience
Audit Experience
MDQMS Project Experience
Other Requirements
PECB Certificate Holder in ISO 13485 Foundation
Pass the PECB ISO 13485 Foundation Exam
None required
None required
None required
Sign the PECB Code of Ethics
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.
