Why should you attend?
The ISO 13485 Foundation training provides an introduction to implementing and managing a Medical Devices Quality Management System (MDQMS) based on the ISO 13485 standard. During this course, you’ll gain a foundational understanding of MDQMS principles, including policy development, procedural guidelines, performance measurement, management commitment, internal auditing, management reviews, and continuous improvement.
Upon completing this course, you can take the certification exam to become a “PECB Certificate Holder in ISO 13485 Foundation.” This credential demonstrates your grasp of the essential methodologies, requirements, framework, and approach for managing medical device quality effectively.
Who should attend?
- Individuals involved in Medical Devices Quality Management
- Professionals aiming to gain knowledge of Medical Devices Quality Management Systems (MDQMS)
- Individuals interested in pursuing a career in Medical Devices Quality Management
Learning objectives
- Understand the elements and functions of a Medical Devices Quality Management System (MDQMS)
- Recognize the correlation between ISO 13485 and other standards and regulatory frameworks
- Comprehend the approaches, methods, and techniques used for implementing and managing an MDQMS
Educational approach
- Lecture sessions supplemented with practical questions and examples
- Practical exercises with case studies and group discussions
- Practice tests designed to reflect the Certificate Exam format
Prerequisites
- None
Course Agenda
- Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts per ISO 13485 requirements
- Day 2: Overview of MDQMS requirements and Certificate Exam
Examination
The ISO 13485 Foundation Exam meets the standards of the PECB Examination and Certification Programme. It covers two key domains:
- Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Domain 2: Medical Devices Quality Management System (MDQMS)
For details on exam format, language options, and other specifics, please contact us .
Certification Requirements
To attain the ISO 13485 Foundation certification, candidates must fulfill the following criteria:
| Designation | Exam | Professional Experience | MDQMS Audit/Assessment Experience | MDQMS Project Experience | Other Requirements |
|---|---|---|---|---|---|
| PECB Certificate Holder in ISO 13485 Foundation | Pass the PECB ISO 13485 Foundation Exam | None | None | None | Signing the PECB Code of Ethics |
Additional Information
- Certification and Examination Fees: Included in the training course price
- Training Materials: Comprehensive course materials with over 200 pages of detailed information and practical examples
- Continuing Professional Development (CPD): Participants receive an attestation of course completion worth 14 CPD credits
- Exam Retake: If unsuccessful, you can retake the exam within 12 months at no additional cost
This certification confirms your knowledge of MDQMS essentials and enables you to support the delivery of safe, high-quality medical devices.
