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?
This training course is intended for individuals involved in Medical Devices Quality Management; individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS); and individuals interested in pursuing a career in Medical Devices Quality Management.
Learning Objectives
Participants will 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; and understand the approaches, methods, and techniques used for the implementation and management of a MDQMS.
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.
Prerequisites
There are no prerequisites to participate in this training course.
The course covers two days of content and carries 14 CPD credits. In the self-study format you cover the same material at your own pace.
Yes. The course fee includes the PECB certification and examination fees. If you do not pass, one complimentary retake is available within 12 months of your first attempt.
There are no prerequisites to participate in this training course.
It is available as self-study (English). Choose the format and language before adding the course to your cart.
There is no scheduled live class for this course at the moment. Organizations that want a dedicated live session can contact us at [email protected].
PECB issues the certificate. After passing the exam you can apply for the PECB credential for this course. Horus Academy is a PECB Authorized Silver Partner and does not issue the certificate itself.
The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:
Domain 1:Â Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Domain 2:Â Medical Devices Quality Management System (MDQMS)
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 |
Course agenda
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
