Quality management systems for Medical Devices (5 cr)

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