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Thursday, March 28, 2024
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Medical Device Regulatory Affairs: Australian Requirements for Registration

Medical Device Regulatory Affairs: Australian Requirements for Registration Certification Training


Program/Course ID:MDA2
Enrollment Period:12 months.
Average Learning Time:~.
Additional Resources:Supplemental materials/activities.
Credit Hours:3 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 UPDATE:
This program is currently unavailable for enrollment.

It may have been updated or discontinued.
Check for newer version in our catalog.


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Outline:


INTRODUCTION
1. Welcome
2. Introduction
3. Assessment
4. Overview

MANUFACTURER ACTIVITIES
5. Intended Purpose
6. Classification System
7. Risk Factors
8. Special Classification Rules
9. Review

GMDN CODE
10. Introduction

11. GMDN Categories
12. Device Groups and Device Types

CONFORMITY ASSESSMENT
13. Introduction
14. Declaration of Conformity
15. Conformity Assessment Procedures
16. Conformity Assessment Procedures
CLASSIFICATION
17. Conformity Assessment Certification
18. Global Mutual Recognition
19. Review

TECHNICAL DOCUMENTATION
20. Introduction
21. Product Description
22. Technical Requirements
23. Design
24. Review

CLINICAL EVIDENCE
25. Introduction
26. When Is Clinical Evidence Needed?
27. Experimental Medical Devices
28. Review

REGISTRATION PROCESS
29. Introduction
30. Starting the Process
31. Manufacturer Evidence
32. Submit Application
33. TGA Inclusion Certificate
34. Review

CONCLUSION
35. Summary

Objectives:


Explain the term 'intended purpose'.
Explain the structure of the classification system.
Describe the impact of risk on classifications.
Explain what clinical evidence needs to be demonstrated.
Describe the key sections of the technical file.

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Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
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Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
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