Med. Device Dev. Regulation | Intercampus Course Exchange

UMass Lowell

Continuing Education

Course not available for

UMass Amherst, UMass Chan Medical School

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.

Plastics Engineering

Course Number

PLAS.5020

Section

031V

Instructor Name

Panchal,Rahul Rameshchandra

Instructor Email

Rahul_Panchal@uml.edu

Prerequisite

CSCE Graduate Restrictions

Schedule & Modality

Tu, 6:30 PM - 9:20 PM

Hyflex

Enrollment Numbers

Capacity

How to Register

In order to register for an ICX course, students must fill out the ICX registration form. The form must be signed by the student's advisor or graduate coordinator, by the department chair or appropriate person. The form is sent to the host campus and is signed by the department chair and instructor of the course. If there are seats available, the student will be enrolled. A shadow course will be created on the student’s home campus allowing the credit to be added to the student’s transcript. The UMass registrars will ensure that proper credits are given to the student and that no charges incur from the host campus.