Mar 28, 2024  
2021-2022 University Catalog 
    
2021-2022 University Catalog [ARCHIVED CATALOG]

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.Credits: 3.00