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Tuesday, October 15, 2019
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Medical Device Regulatory Affairs: US Overview (MDU1)

Certification Training
Rated 3.67/5
12 reviews
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: US Overview
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute Reviews

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 BioPharma Institute

The BioPharma Institute 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 BioPharma Institute provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The BioPharma Institute 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) 424-6576 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.

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


1. Welcome
2. Introduction
3. Reviews and Assessment

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

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

20. Summary


--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.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, 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 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

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

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