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About Course
We are currently revising this course. The updated version is expected in December 2024.
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A Deep Dive into how to create and maintain a Quality Management System for medical devices in line with ISO 13485.
This course provides a comprehensive guide to cover all essential aspects of Quality Management Systems and ISO 13485. Each module focuses on a specific area of ISO 13485 requirements, with practical applications. We also explore regional specific requirements for quality management for a well-rounded learning experience.
Course Content
Introduction and Background
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Welcome!
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Instructor Tips
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Course Scope
Quality Management Systems (QMS) and Medical Devices
Introduction to ISO 13485
Context of the Organization
Leadership and Commitment
Planning of the QMS
Resourcing and Support
Operations
Performance Evaluation
Improvement
ISO 13485 Certification Process and Best Practices
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