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Tuesday, February 21, 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).
Credits Hours: 4
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $395.00

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 these are contained within the Code of Federal Regulations (CFRs) — 21 CFR Part 800 series. This course introduces you to some of these regulations.

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 the knowledge required in order to implement a quality system in accordance with the 21 CFR 820 regulations.

Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme: This course will introduce you to the activities that are required before a device is ready to go to market in the US. The MDU-1 US Regulatory Affairs Overview course is a useful introduction to This online course.

Training Provided By: BioPharma Institute

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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