SeerPharma Pty Ltd :: DISCover web-based training :: MD-G 1: Global Regulation of Medical Devices

UK | Singapore

MD-G 1: Global Regulation of Medical Devices

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.

Price: $149 (AUD)

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

COURSE OBJECTIVES

Students completing this course should be able to:

Define the term medical devices
Describe the medical device classification system
Recognise 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

SeerPharma is grateful for the endorsement of the DISCover Medical Devices series by:

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