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.
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 Certification Exam
The “PECB Certified ISO 13485 Foundation” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:
For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485.More Information