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Thursday, March 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).
Credits Hours: 4
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $395.00

Description: This program provides an introduction to the Code of Federal Regulations (CFRs); assimilates the knowledge required in order to implement a quality system in accordance with the 21 CFR 820 regulations; introduces you to the activities that are required before a device is ready to go to market in the US.
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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 recommended as a introduction before taking this course.


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