Description
Medical devices are regulated globally by a series of rules and regulations designed to produce a safe and effective device. This module takes you through an overview of global medical device regulations.
Course Objectives
Students completing this course should be able to:
- Define the term medical devices
- Describe the medical device classification system
- Recognize that medical device classification systems are based on risk
- Identify the major regulatory agencies
- Identify the regulatory requirements during a product's lifecycle
- Outline the steps required to ensure that a device meets registration requirements
- Outline the steps required to obtain a license to manufacture
Course Outline
INTRODUCTION
1. Welcome
2. Introduction
3. Assessment
OVERVIEW
4. Introduction
5. Overview
6. Regulatory Bodies and Important Agencies
7. Definitions
8. Classification of Medical Devices
9. Factors in Classification
10. Registration
11. Medical Device Life Cycle
12. Review
CONCLUSION
13. Summary