Spring 2025
> Engineering/Engineering Technology
> PLAS.5020
> 031V
Course No: PLAS.5020-031V; SIS Class Nbr: 13552; SIS Term: 3430
Course Status: Open
Course Description
Comprehensive and in-depth analysis of US medical device diagnostics development and approval requirements. Detailed analysis of quality assurance issues and regulatory reforms implemented under the Food and Drug Administration. Provides a step-by-step guide through the Center for Devices and Radiological Health (CRDH) investigational device exemptions, premarket approval, 510 (k) application process, and product development protocol and review processes.
Prerequisites, Notes & Instructor
- Prerequisites: Students with a CSCE career need permission to take Graduate Level Courses.
- Section Notes: HyFlex Course
- Core Codes: STEM, HYFX
- Credits: 3; Contact Hours: 3
- Instructor: Rahul Panchal
-
UMass Lowell Bookstore
When Offered & Tuition
- T | 6:30 PM-9:20 PM ET Online
- 2025 Spring: Jan 21 to May 08
- Course Level: Graduate
-
Tuition: $2250
- Note: There is a $30 per semester registration fee for credit courses.
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