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Tuesday, December 11, 2018
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Medical Device Regulatory Affairs: Australian Requirements for Registration (MDA2)

Certification Training Duration: 1.7 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $169.00

BioPharma Institute LogoTraining Program: Medical Device Regulatory Affairs: Australian Requirements for Registration
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This is an online program offers training with immediate access upon enrollment. The students will be introduced to the specifics that are required before a medical device is qualified to go to market. The program will explain Global Medical Device Nomenclature (GMDN) codes, the medical device classification system, it’s intended purpose, and conformity assessment certification systems for devices that are registered with the Therapeutic Goods Administration (TGA) in Australia. The course objectives describe the technical file’s key sections, explain what clinical evidence needs to be demonstrated, describe the impact of risk on classifications, and explain the structure of the classification system and the term ‘intended purpose’. The program consists of an introduction and sections covering the GMDN code, manufacturer activities, conformity assessment, GMDN categories, clinical evidence, technical documentation, the registration process, and a conclusion which reviews the previously listed topics.

Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can take the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at BioPharma Institute

The BioPharma Institute has proudly and successfully provided online training solutions to thousands of corporations, both abroad and within the United States, and has assisted countless individuals in the healthcare, biotechnology, and pharmaceutical industries. We can help you and your company further your understanding of the industry and the peripheral technologies within it.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The Medical Device Regulatory Affairs: Australian Requirements for Registration course is found in the following professional certification program(s):


Australian Medical Device Regulatory Affairs Professional Certification Program: The Australian Medical Device Regulatory Affairs Professional Certification Program will introduce to students the activities that are required before a medical device is ready to go to the Australian market.Th … Learn more


COURSE 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

COURSE 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.


For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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