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Tuesday, December 11, 2018
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Medical Device Regulatory Affairs: Global (MDG1)

Certification Training Duration: 1.5 hours (the average time to complete the training program, including final assessments).
Credits Hours: 1
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 $149.00

BioPharma Institute LogoTraining Program: Medical Device Regulatory Affairs: Global
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

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. This online course guides you through an overview of regulations that apply to global medical devices. This course is also found in the Global Medical Device Regulatory Affairs Professional Certification Program. The objectives of this course are to outline the steps needed to obtain a manufacturer license, outline the steps needed to ensure that a device meets registration requirements, identify the regulatory requirements during the lifecycle of a product, to identify the major regulatory agencies, recognize the classification system of medical devices, and will define the term ‘medical devices’.

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

By employing advanced e-learning training techniques, and coupling them with automated tracking systems, the BioPharma Institute is helping companies, both abroad and within the US, by maintaining training records, teaching their employees, and improving their overall service quality. We can assist you, your colleagues, or your employees to succeed and advance corporate and career objectives.

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.

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: Global course is found in the following professional certification program(s):

Global Medical Device Regulatory Affairs Professional Certification Program: This Global Medical Device Regulatory Affairs Professional Certification Program is an online program which guides the student through a global medical device regulations overview. It discusses how ISO13485:200 … Learn more


1. Welcome
2. Introduction
3. Assessment

4. Introduction
5. Overview
6. Regulatory Bodies and Important Agencies
7. Definitions
8. Classification of Medical Devices
9. Factors in Classification
10. Registration
11. Medical Device Life Cycle
12. Review

13. Summary


Define the term medical devices.
Describe the medical device classification system.
Recognize that medical device classification systems are based on risk.
Identify the major regulatory agencies.
Identify the regulatory requirements during a product`s lifecycle.
Outline the steps required to ensure that a device meets registration requirements.
Outline the steps required to obtain a license to manufacture.

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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