Program Overview

University Program Information

The University of Massachusetts Lowell offers a range of programs for students.

Program Details

• The university provides various programs, including Associate's, Bachelor's, Master's, Doctoral, and Post Master's Certificates.
• Professional training options are available in areas such as AI, Plastics, Project Management, and more.
• Programs are offered in different subjects, including Business, Finance & Economics, Criminal Justice & Security Studies, Cybersecurity, Education, Engineering/Engineering Technology, English & Liberal Arts, Health Sciences, Information Technology, Mathematics, and Psychology.

Course Description

Medical Device Development Regulation

• The Medical Device Development Regulation course provides a comprehensive and in-depth analysis of US medical device diagnostics development and approval requirements.
• The course covers quality assurance issues and regulatory reforms implemented under the Food and Drug Administration.
• It offers 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, and Instructor

• Prerequisites: Students with a CSCE career need permission to take Graduate Level Courses.
• Section Notes: HyFlex Course
• Core Codes: STEM, HYFX, NO COST
• Credits: 3; Contact Hours: 3
• Instructor: Rahul Panchal
• Materials: No cost course materials available

When Offered and Tuition

• The course is offered on Tuesdays from 6:30 PM-9:20 PM ET Online.
• The spring 2026 semester runs from January 20 to May 09.
• Course Level: Graduate
• Tuition: $2250
• Note: There is a $30 per semester registration fee for credit courses.

Academic Policies

• The Division of Graduate, Online & Professional Studies reserves the right to implement new rules and regulations and to make changes of any nature to its program, calendar, procedures, standards, degree requirements, academic schedules, locations, tuition, and fees.
• Whenever possible, appropriate notice of such changes will be given before they become effective.