Global Medical Device Regulatory Affairs Professional Certification Program (MD00S1)
|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
The Global Medical Device Regulatory Affairs Professional Certification Program Includes the Following Individual Courses:
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 Support@BioPharmaInstitute.com.