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Detailed Course Information

 

Fall 2021
Dec 02, 2022
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BME 56300 - Quality Systems For Regulatory Compliance
Credit Hours: 3.00. Medical devices are developed and manufactured in a highly regulated environment. This course will provide an introduction, overview, and systematic study of the intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices. Focus is on understanding the critical elements of regulatory science and quality compliance from a design control perspective. Instruction and mentoring in regulatory science skills is provided by academics and industry representatives with expertise in their fields. This course is part of a three-course series.
3.000 Credit hours

Syllabus Available
Levels: Undergraduate, Graduate, Professional
Schedule Types: Distance Learning, Lecture

Offered By: School of Biomedical Engr
Department: Weldon Schl of Biomedical Engr

Course Attributes:
Upper Division

May be offered at any of the following campuses:     
      West Lafayette Continuing Ed
      West Lafayette

Learning Outcomes: 1. Demonstrate a functional understanding of regulatory compliance for biomedical devices. 2. Use the main tools within the quality craft (Ex: confidence interval, control chart, difference between a T-test and F-test). 3. Demonstrate understanding of how the FDA approaches control.


Restrictions:
May not be enrolled as the following Classifications:     
      Sophomore: 45 - 59 hours
      Sophomore: 30 - 44 hours
      Freshman: 0 - 14 hours
      Freshman: 15 - 29 hours

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