PLST2031 Systematic Medical Device Protocol
This course is a in deep dive into the processes and procedures needed to bring a medical device from concept to Food and Drug Administration (FDA) approval. Students will be introduced to the concepts, principles and specific requirements regarding FDA and Good Manufacturing Practices (GMP) that strictly regulate how organizations must adhere to a systematic approach to the production of medical devices in America and across the world.
Prerequisite
None
Course Requirements and Evaluation
Refer to Course Syllabus for detailed information regarding the requirements and evaluation standards for this course. The Course Syllabus will be distributed the first week of the course.
Learning Outcomes
The following outcomes will be addressed in the course:
Explain the role of the FDA in American society
Identify FDA regulations pertaining to medical devices
Identify steps needed for quality system implementation
Identify documentation needed for medical device FDA submission
Create factory acceptance and calibration schedules for equipment
Explain design and process failure mode documentation
Create OQ/PQ run plan
Document OQ/PQ run data
Create DOE run plan
Document DOE run data
Explain process validation processes
Demonstrate proper GMP documentation
Explain document change protocols and procedures
Text and References
A list of textbooks required for this course is available at the
campus store and in eServices.
Course Scheduling
The scheduled hours of instruction include sixteen hours for each lecture credit, thirty-two hours for each lab credit, and forty hours for each credit of supervised occupational experience (SOE). Lecture credit may include formal or impromptu lectures, demonstrations, or discussions with the entire class or with small groups or individuals. Refer to the Course Credits section of this course outline for the credit breakdown.
Accommodations Statement
Access Services - Reasonable accommodations are available to qualified students with documented disabilities. Upon attending an intake meeting with Access Services, qualified students will receive a letter listing the approved accommodations that they may provide to their instructors. If you have a documented disability that may require accommodations, contact HTC Access Services at
AccessServices@hennepintech.edu or
https://hennepintech.edu/current-students/access-services/index.html.
Campus
Brooklyn Park Campus: 952-995-1300
Credit Details