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 Certified ISO 13485 Foundation" credential. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.
Who Should Attend?
Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
Medical Devices Quality Management System requirements and Certification Exam
The "PECB Certified ISO 13485 Foundation" exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam 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)
After successfully passing the exam, you can apply for the credential shown on the table below. You will receive the certificate once you comply with all the requirements related to the selected credential. Certification fees are included in the exam price.
PECB Certified ISO 13485 Foundation
PECB Certified ISO 13485 Foundation exam or equivalent
Signing the PECB Code of Ethics
* = Required
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