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Tuesday, June 27, 2017
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Medical Device Regulatory Affairs: US Overview (MDU1)

Certification Training Duration: 1.7 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $169.00

dinaris.org LogoTraining Program: Medical Device Regulatory Affairs: US Overview
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

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 course introduces the student to a number of these regulations. Course objectives include a comparison of the characteristics of required regulatory control for each of the various classes of medical devices, a description of the classification system of medical devices, how to locate the medical device regulations pertaining to particular areas of the industry, and a definition of important medical device terminology. The course includes an introduction and topics such as regulatory control and the classification system, an overview of the US regulatory system, and a conclusion summarizing those topics.

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

Benefits of Getting Certified at dinaris.org

The dinaris.org has worked proudly with thousands of companies in the healthcare, biotechnology, and pharmaceutical industries. By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at 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, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Medical Device Regulatory Affairs: US Overview Course is Found in the Following Professional Certification Program(s):


US Medical Device Regulatory Affairs Professional Certification Program: This online certification program provides an introduction to the Code of Federal Regulations (CFRs). It introduces students to the activities that are essential prior to a device being set to go to the United … Learn more

COURSE OUTLINE:


INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and Assessment

OVERVIEW OF THE USA REGULATORY SYSTEM
4. USA Medical Device Industry
5. Medical Device Definition
6. The Food & Drug Administration (FDA)
7. Historical Perspective
8. Regulations
9. Review

CLASSIFICATION SYSTEM AND REGULATORY CONTROL
10. Medical Device Classification
11. Important Terminology
12. Example
13. Regulatory Control and Classification
14. General Controls
15. Special Controls
16. Premarket Approval
17. Classifications and Exemptions
18. Special Considerations
19. Review

CONCLUSION
20. Summary

COURSE OBJECTIVES:


–Define important medical device terminology.
–Locate the medical device regulations pertaining to particular areas of the industry.
–Describe the classification system of medical devices.
–Compare the characteristics of regulatory control required for each of the different classes of medical devices.

JOB POSTINGS:

608 Device Regulatory jobs found.
Displaying jobs #1-4.

Senior Device Developer – ASE 5
Posted Date: 2017-06-24
Kforce Technology – United States, CA, San Leandro, 94577

Director, Regulatory Affairs Promotional Materials
Posted Date: 2017-06-25
Pharmacyclics – United States, CA, Sunnyvale, 94091

Medical Device Sales Representative
Posted Date: 2017-06-24
Hiossen Inc – United States, FL, Tampa, 33646

Medical Device Laboratory Technician (Lab Tech)
Posted Date: 2017-06-23
Medix – United States, IL, Mundelein, 60060

See more Device Regulatory Jobs


For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.

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