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.

Course Thumbnail
ZAR 4,784.00
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

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