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Thursday, March 23, 2017
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Global Medical Device Regulatory Affairs Professional Certification Program (MD00S1)

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 takes you through an overview of global medical device regulations; explains how the ISO standard (ISO13485:2003) relates to the medical device industry, identifies vital elements of the standard and essential administration roles, and details the regulatory expectations for QMS certification (The key differences between ISO9000 QMS and ISO13485 medical device QMS are presented and discussed); explains the terminology and identifies the risk management processes, discusses how risk can be calculated, and details all the documentation required.
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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



Medical Device Regulatory Affairs: Global: Medical devices are regulated globally by a series of rules and regulations designed to produce a safe and effective device. This online course takes you through an overview of global medical device regulations.

Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements: This course explains how the ISO standard (ISO13485:2003) relates to the medical device industry, identifies vital elements of the standard and essential administration roles, and details the regulatory expectations for QMS certification. The key differences between ISO9000 QMS and ISO13485 medical device QMS are presented and discussed.

Medical Device Regulatory Affairs: Global Risk Management: Explains the terminology and identifies the risk management processes, discusses how risk can be calculated, and details all the documentation required.


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