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Medical Device Regulatory Affairs: Australian Requirements for Registration (MDA2)

Certification Training
 
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Duration: 1.7 hours, Online (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. BioPharma Institute Reviews

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.

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.

All Courses in the Medical Devices Catalog:


Medical Device Regulatory Affairs: Australian Overview: This online program is an overview of Australian regulatory affairs. The course objectives are to describe the systems of classification for medical devices; define the roles of the regulator, manufacturer, and ... Learn more

Medical Device Regulatory Affairs: Australian Requirements for Registration: 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 prog ... Learn more

Medical Device Regulatory Affairs: Global: This is an online program offering training with immediate access upon enrollment. Medical devices are globally regulated by a series of regulations and rules designed to produce an effective and safe device. T ... Learn more

Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements: This course details the regulatory expectations for quality management system (QMS) certification, identifies vital elements of the essential and standard administration roles, and explains how ISO 13485:2003 ( ... Learn more

Medical Device Regulatory Affairs: Global Risk Management: This online program explains relevant risk management terminology. The course identifies the process of risk management, details all of the documentation required, and discusses how risk can be calculated. Cour ... Learn more

Medical Device Quality Management: Managing a QMS: This course teaches the student about the maintenance of a quality management system (QMS). Course objectives include training how to recognize the importance of measuring performance, illustrating how the inte ... Learn more

Medical Device Quality Management: Documentation and Records: Control, implementation, and development of documentation and records provide the foundation of a quality management system (QMS). It also provides the evidence of compliance with the FDA CFR 820 Quality System ... Learn more

Medical Device Quality Management: CAPA Systems: The ability to correct and identify existing problems and implement controls to prevent potential problems is essential for efficient quality management processes, safety products, and continued customer satisf ... Learn more

Medical Device Regulatory Affairs: US Overview: The medical device industry in the USA is governed by a number of important regulations, the most important of those being contained within the CFRs (code of federal regulations) - 21 CFR part 800 series. This ... Learn more

Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820: Implementing a quality system for medical devices can be a complex process. This model will help you to assimilate all of the required knowledge necessary to implement a quality system in accordance with the 21 ... Learn more

Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme: This course introduces the student to the required activities necessary before a device is ready to go to market in the United States. The US Regulatory Affairs Overview (MDU1) course is recommended as an intro ... Learn more

An Introduction to the Regulation of Medical Devices: This program provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA. We explain what me ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
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  • Self-paced courses: 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
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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