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Detailed Course Information

 

Fall 2014
Mar 29, 2024
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Information Select the desired Level or Schedule Type to find available classes for the course.

BME 5304 - BME Device Design & Regulation
This course introduces the regulatory requirements for the design, testing, and clinical implementation of medical devices and biologics. The first part covers the FDA regulatory process. The second part covers key legal and policy issues involved in a clinical organization: Health Insurance Portability and Accountability Act and Joint Commission on the Accreditation of Health Care Organizations rules on risk management, standards, regulations, compliance and ethics. Prerequisites: BME 5301 or 6301 and BME 5302 or 6302 with a grade of "C" or better; may be taken concurrently. Departmental approval also required. Restricted to level of GR.

3.000 Credit hours
3.000 Lecture hours
0.000 Lab hours
0.000 Other hours

Levels: Graduate
Schedule Types: Lecture (LECT)
Course Fee(s): None.

College of Engineering (Dean) Department

Restrictions:
Must be enrolled in one of the following Levels:     
      Graduate
Must be enrolled in one of the following Campuses:     
      Main Campus

Prerequisites:
Prerequisites for BME 5304

General Requirements:
Course or Test: BME 5301
Minimum Grade of C
May be taken concurrently.  )
or
Course or Test: BME 6301
Minimum Grade of C
May be taken concurrently.  )
and
Course or Test: BME 5302
Minimum Grade of C
May be taken concurrently.  )
or
Course or Test: BME 6302
Minimum Grade of C
May be taken concurrently. )


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