SYSTEMATIC MEDICAL DEVICE PROTOCOL
- Program: Plastics Engineering Technology
- Course: Systematic Medical Device Protocol
- Course #: PLST2030
- Total Credits: 3
Course DescriptionThis course introduces students to the concepts, principles and specific requirements regarding Food and Drug Administration (FDA) and Good Manufacturing Practices (GMP) that strictly regulate how organizations must adhere to a systematic approach to the production of medical devices.
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.
Hennepin Technical College offers reasonable accommodations to qualified students with disabilities. If you have a documented disability that may require accommodations, contact the college’s Disability Services Director: Sara Laviolette at Brooklyn Park (763-488-2477) or Jean Kreutter at Eden Prairie (952-995-1544).
The following goals will be addressed in the course:
Identify quality system regulations
Identify with quality systems
Identify with design controls
Identify with process validation
Identify with equipment and calibration
Complete device master records
Determine document change control
Analyze product evaluations
Show awareness of quality system audits
Show awareness of factory inspections
- Lecture: 2
- Lab: 1
MnTC Goal: 0
- Campus: Brooklyn Park
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