MDI 5008 is also offered in Fall 2024
MDI 5008 is also offered in Fall 2023
MDI 5008 is also offered in Spring 2022
MDI 5008 is also offered in Summer 2021
Summer 2019 | MDI 5008 Section 001: Quality, Regulatory and Manufacturing Management (87775)
- Instructor(s)
- Class Component:
- Lecture
- Credits:
- 2 Credits
- Grading Basis:
- A-F only
- Instructor Consent:
- No Special Consent Required
- Instruction Mode:
- In Person Term Based
- Times and Locations:
Summer Session 13 wk
Mon,
Wed 05:30PM - 09:30PM
UMTC, East Bank
Folwell Hall 112
- Enrollment Status:
Open (12 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.
- Textbooks:
- https://bookstores.umn.edu/course-lookup/87775/1195
ClassInfo Links - Summer 2019 Medical Device Innovation Classes