Regulatory Requirements of Devices and Software (5 cr)

Objectives (course unit)

The course provides the skills to take into account the regulatory requirements of health technology in product development, sales and professional use.

After completing the course, the student
- broadly masters entirety of regulatory requirements and documentation requirements for medical devices and medical device software
- is able to apply regulatory requirements in design and development of medical devices and medical device software
- knows how to implement the CE marking and conformity assessment process for medical devices and medical device software.

Content (course unit)

Key terminology and concepts of health and wellbeing technology
Regulatory requirements for medical devices and medical device software
Obligations of manufacturers, supply chain operators and professional users
Classification of medical devices and medical device software
General safety and performance requirements
Clinical evaluation and clinical investigations
Device risk management
Conformity assessment of medical devices and medical device software
CE marking of medical devices and medical device software

Assessment criteria, satisfactory (1-2) (course unit)

The student
- is able to describe the entirety of regulatory requirements of medical devices and medical device software
- can prepare a basic level description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, but is not able to classify devices
- is able to describe requirements for medical devices and medical device software in different phases of their life cycle

Assessment criteria, good (3-4) (course unit)

The student
- is able to describe and prepare the regulatory requirements of medical devices and medical device software
- is able to prepare a description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, and is able to classify devices
- is able to describe and interpret requirements for medical devices and medical device software in different phases of their life cycle

Assessment criteria, excellent (5) (course unit)

The student
- is able to describe, prepare and apply regulatory requirements of medical devices and medical device software
- is able to prepare and evaluate a description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, and is able to choose and justify the classification of and conformity assessment procedure for devices
- is able to describe, interpret and apply requirements for medical devices and medical device software in different phases of their life cycle
- knows how to work in different organizations to ensure safety and safe use of devices

Assessment scale

0-5