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Wednesday, August 23, 2017
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US Medical Device Regulatory Affairs Professional Certification Program (MD00S2)

Certification Training Duration: 4 hours (the average time to complete the training program, including final assessments).
Credit Hours: See individual courses for credit hours assigned.
Catalog: Medical Device Regulatory Affairs
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $395.00


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 States market. Additionally, it assimilates the knowledge needed in order to execute a quality system in accordance with the 21 CFR 820 regulations. The following individual courses are included in this online program: US 501K Premarket Notification Scheme; US Quality Systems Requirements, 21 CFR 820; and US Overview of Medical Device Regulatory Affairs.

Once all course requirements have been satisfied, a professional certification has been achieved. 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

BioPharma Institute utilizes e-learning courses that make it convenient for businesses to educate their employees, allowing for a flexible schedule that doesn’t require employees to set aside time to attend live classes. For two decades, we have been offering solutions and online training for thousands of organizations throughout the biotechnology, pharmaceutical, and healthcare industries. We can provide you with the education needed to further your career or refresh your skills.

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.

Training Provided By: BioPharma Institute

BioPharma Institute LogoThe US Medical Device Regulatory Affairs Professional Certification Program Includes the Following Individual Courses:

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

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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