Course Objectives

Introduction:

Quality Management Systems for Medical Devices ISO 13485 training course 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. Training course 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. During this training course from Gulf Training and Consultation Center, 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.

Learning Objectives:

• 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
• 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.

Educational Approach:

• Lecture sessions are illustrated with practical questions and examples
• Practical exercises include examples and discussions.
• This training is based on both theory and best practices used in ISO 15378 audits

Why Gulf Training and Consultation Center ?

• We have a large pool of experienced and professional auditors that are qualified internationally.
• The competency of our multi-disciplined auditors adds value and credibility to our certificates.

Content

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Course Target

Who should attend?

• Individuals involved in Medical Devices Quality Management.
• Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS).
• Individuals interested to pursue a career in Medical Devices Quality Management.
• Managers or consultants involved in Medical Devices Quality Management.
• Expert advisors seeking to master the implementation of a Medical Devices Quality Management System.
• Individuals responsible for maintaining conformance with MDQMS requirements.
• MDQMS team members.