Fall 2023  |  MDI 5008 Section 001: Quality, Regulatory, and Operations Management (32309)

Instructor(s)
Class Component:
Lecture
Credits:
3 Credits
Grading Basis:
A-F or Audit
Instructor Consent:
No Special Consent Required
Instruction Mode:
In Person
Enrollment Requirements:
Medical Device Innovation M S
Times and Locations:
Extended Regular Session
 
10/10/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
10/17/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
10/24/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
10/31/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
11/07/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
11/14/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
11/21/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
11/28/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
12/05/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
12/12/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
 
12/19/2023
Tue 05:30PM - 09:30PM
UMTC, East Bank
McNamara Alumni Center 235
Enrollment Status:
Open (8 of 15 seats filled)
Also Offered:
Course Catalog Description:
MDI 5008 is built on understanding and applying the Total Product Life Cycle (TPLC) and Product Development Stage Gate methodologies as they relate to the global quality and regulatory environment in which the medical device industry operates. This is a practicum-based course using authentic FDA and ISO requirements to prepare the real-world documents and reports that are associated with the development of medical devices through to commercialization (pre-market to post-market) and includes key Operations Management principles that translate to delivering the product to market. The framework of the course and materials studied focus on effectively navigating the regulatory labyrinth to bring new and novel medical devices to market.
Class Notes:
Class meets on the following dates: 10/10, 10/17, 10/24, 10/31, 11/7, 11/14, 11/21, 11/28, 12/5, 12/12, and 12/19 from 5:30 PM - 9:30 PM in McNamara 235.
Class Description:
Student may contact the instructor or department for information.
Textbooks:
https://bookstores.umn.edu/course-lookup/32309/1239

ClassInfo Links - Fall 2023 Medical Device Innovation Classes

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