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| BME 56300 - Quality Systems For Regulatory Compliance |
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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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