Summer 2020  |  MDI 5008 Section 001: Quality, Regulatory and Manufacturing Management (85359)

Class Component:
2 Credits
Grading Basis:
Student Option No Audit
Instructor Consent:
No Special Consent Required
Instruction Mode:
Completely Online
Class Attributes:
Online Course
Times and Locations:
Summer Session 13 wk
05/18/2020 - 08/14/2020
Off Campus
Virtual Rooms ONLINEONLY
Enrollment Status:
Open (13 of 30 seats filled)
Also Offered:
Course Catalog Description:
Course provides students with understanding of the global regulatory environment in which the medical device industry operates. Students gain a fundamental understanding of critical quality systems regulations including ISO13485/ISO14971 and their relationship to the FDA's cGMP regulations. Students gain practical experience using tools that are essential to both product development and continuation/sustaining engineering including; design control procedures, FMEA, verification and validation, internal and external (supplier) management and audit methods. prereq: MDI graduate student only
Class Description:
Student may contact the instructor or department for information.

ClassInfo Links - Summer 2020 Medical Device Innovation Classes

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