- Why
- Who
- Objectives
- Approach
- Prerequisites
- Agenda
- Examination
- Certification
- CPD Credits
- Brochure
- Format
- Delivery
- Language
Why should you attend?
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.
Who should attend?
- 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
- 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
- Lecture sessions are illustrated with practical questions and examples
- Practical exercises include examples and discussions
- Practice tests are similar to the Certificate Exam
None.
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
The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:
Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Domain 2: Medical Devices Quality Management System (MDQMS)
For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
After successfully completing the exam, you can apply for the credential shown on the table below.
The certificate requirements for the ISO 13485 Foundation are:
| Designation | Training Course | Exam | Professional experience | MS audit/assessment experience | BCMS project experience | Other requirements |
| PECB Certificate Holder in ISO 13485 Foundation | PECB ISO 13485 Foundation | Pass the PECB ISO 13485 Foundation Exam | None | None | None | Signing the PECB Code of Ethics |
- Certificate 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
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Self Study | Learn more |
To access your training, you’ll need a PECB account:
- If you don’t already have one, please register here: https://sso.mypecb.com/Account/Register
- After registering, send us the email address you used along with your full name (Name and Surname) to admissions@cybertech.academy
- Once we receive your details, we will push the training to your account within 12 hours.
Check Language Availability for PECB Trainings and Exams
Before enrolling, you can verify in which languages the PECB training materials and exams are available.
Use the official PECB resources below for the most accurate and up-to-date information.
Official PECB Resources
- Exam Languages (List of PECB Exams):
https://help.pecb.com/index.php/list-of-pecb-exams/ - Training Material Languages (List of PECB Courses):
https://help.pecb.com/index.php/course-version/
How to Use
For Exams:
Visit the List of PECB Exams page and type the ISO standard code (e.g., ISO 27001, ISO 9001, ISO 42001) in the search box.
You can also add a language (e.g., French 9001) to check if the exam is available in that language.
For Trainings:
Visit the List of PECB Courses page to see which training materials are available in specific languages for each course and level (e.g., Foundation, Lead Implementer, Lead Auditor).
Example Searches:
ISO 9001 >> shows all languages available for ISO 9001
ISO 27001 Spanish >> shows Spanish availability for ISO 27001
Important Note:
Exam and training availability may differ.
If an exam is available in a specific language, it does not always mean the training materials are available in the same language.
Please refer to both links above for confirmation.