Quality Management Systems for Medical DevicesLaajuus (5 cr)
Code: 7Y00GE86
Credits
5 op
Objectives
The course provides the skills to create a quality management system that meets the regulatory requirements for medical devices, and to work in an expert position accordingly.
After the course, the student
- knows the key terminology of quality and quality management
- understand the basics and benefits of quality management
- knows the regulatory requirements for quality management of medical devices
- is able to plan and implement quality management for medical devices
- is able to analyse whether the regulatory requirements for quality management of health technology are met
Content
Quality, quality management and quality management systems
Basics and benefits of quality management
Quality management and quality management standards of medical devices
Regulatory requirements for the quality management and quality management system of medical devices
Planning, implementing and maintaining the quality management system
Assessment criteria, satisfactory (1-2)
The student
- knows the key terminology of quality and quality management
- knows the basics of quality management
- knows the basics of the regulatory requirements for quality management of medical devices
- is able to define the principles of planning and implementing quality management for medical devices
Assessment criteria, good (3-4)
The student
- knows the key terminology of quality and quality management
- knows the basics of quality management and is able to identify its benefits
- is able to interpret the regulatory requirements for quality management of medical devices
- is able to plan a quality management system for medical devices
Assessment criteria, excellent (5)
The student
- knows the key terminology of quality and quality management
- knows the basics and benefits of quality management, and is able to analyze its benefits
- is able to apply the regulatory requirements for quality management of medical devices
- is able to plan, implement and maintain quality management system for medical devices
- is able to analyse whether the regulatory requirements for quality management of medical devices are met
Enrolment period
27.05.2024 - 31.10.2024
Timing
16.08.2024 - 24.11.2024
Credits
5 op
Mode of delivery
Contact teaching
Unit
MD in Health Technology
Campus
TAMK Main Campus
Teaching languages
- Finnish
Seats
0 - 35
Degree programmes
- Master's Degree Programme in Health Technology
Teachers
- Heidi Peltolehto
Person in charge
Heidi Peltolehto
Groups
-
24YTS
-
24YTL
-
24YTT
Objectives (course unit)
The course provides the skills to create a quality management system that meets the regulatory requirements for medical devices, and to work in an expert position accordingly.
After the course, the student
- knows the key terminology of quality and quality management
- understand the basics and benefits of quality management
- knows the regulatory requirements for quality management of medical devices
- is able to plan and implement quality management for medical devices
- is able to analyse whether the regulatory requirements for quality management of health technology are met
Content (course unit)
Quality, quality management and quality management systems
Basics and benefits of quality management
Quality management and quality management standards of medical devices
Regulatory requirements for the quality management and quality management system of medical devices
Planning, implementing and maintaining the quality management system
Assessment criteria, satisfactory (1-2) (course unit)
The student
- knows the key terminology of quality and quality management
- knows the basics of quality management
- knows the basics of the regulatory requirements for quality management of medical devices
- is able to define the principles of planning and implementing quality management for medical devices
Assessment criteria, good (3-4) (course unit)
The student
- knows the key terminology of quality and quality management
- knows the basics of quality management and is able to identify its benefits
- is able to interpret the regulatory requirements for quality management of medical devices
- is able to plan a quality management system for medical devices
Assessment criteria, excellent (5) (course unit)
The student
- knows the key terminology of quality and quality management
- knows the basics and benefits of quality management, and is able to analyze its benefits
- is able to apply the regulatory requirements for quality management of medical devices
- is able to plan, implement and maintain quality management system for medical devices
- is able to analyse whether the regulatory requirements for quality management of medical devices are met
Assessment scale
0-5