PECB ISO 13485 Medical Devices Quality Management System - Foundation
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.
Skill Level:
Beginner
Duration:
2 days/Self Study
What You'll Learn
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
What's in the course?
Lecture sessions are illustrated with practical questions and examples
Practical exercises include examples and discussions
Practice tests are similar to the Certificate Exam
Course Curriculum
Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
Medical Devices Quality Management System requirements and Certificate Exam
Examination
Certificate Requirements
General Information
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