Understanding ISO 13485:2003 Medical Devices

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Course Outline

Part 1: Introduction

• Terminologies used
• Definition of Quality
• Quality Policy
• Who is the customer?
• CE marking
• FDA approval
• ROW considerations
• Detail on each (important) section of the standard:

Part 2: Regulatory

• CE marking
• FDA approval
• ROW considerations

Part 3: ISO 13485

1. Introduction
2. Scope
3. Normative References
4. Terms & definitions
5. Quality Management System
6. Management Responsibility
7. Resources Management
8. Product Realization
9. Measurement Analysis & Improvement

Part 4: Review

• Review
• Training Assessment