PECB ISO 13485 Medical Devices Quality Management System - Lead Implementer
During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
Skill Level:
Intermediate
Duration:
5 days/Self Study/eLearning
What You'll Learn
Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
Learn how to interpret the ISO 13485 requirements in the specific context of an organization
Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
What's in the course?
This training is based on both theory and best practices used in the implementation of a MDQMS
Lecture sessions are illustrated with examples based on case studies
Practical exercises are based on a case study which includes role playing and discussions
Practice tests are similar to the Certification Exam
Course Curriculum
Introduction to ISO 13485 and initiation of a MDQMS
Plan the implementation of a MDQMS
Implementation of a MDQMS
MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
Examination
Certification
General Information
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