Legislation and Standards Related to Medical Devices (5 cr)

Objective

Upon completion of the course, the student will be familiar with the regulation of medical devices, be able to identify and assess the requirements of medical device regulation, be familiar with relevant standards, guidelines and methods and be able to use them appropriately, and be able to communicate fluently and in a timely manner.

Content

• Medical device regulation in the EU: requirements for medical devices and manufacturers
• Risk and quality management
• Medical device intended use, classification, standards, methods and guidelines
• Practical application of knowledge and skills to a selected medical device or software

Evaluation scale

0-5

Assessment criteria, satisfactory (1)

The student is familiar with the regulation of medical devices. The student will be able to identify and describe the regulatory requirements for medical devices. The student knows and can use relevant standards, guidelines and methods. The student will be able to communicate and report results.

Assessment criteria, good (3)

The student is properly familiar with the regulation of medical devices. The student will be able to identify and assess the requirements of medical device regulation. The student has a good command of relevant standards, guidelines and procedures and can apply them appropriately. The student will be able to communicate and report results clearly within a given timeframe.

Assessment criteria, excellent (5)

The student has an excellent understanding of the regulation of medical devices. The student will be able to identify and critically evaluate the requirements of medical device regulation in a thorough and critical manner. The student has an excellent command of relevant standards, guidelines and methods and is able to apply them appropriately and to a high standard. The student will be able to communicate and report results convincingly within the given timeframe.

Assessment criteria, approved/failed

The student is familiar with the regulation of medical devices. The student will be able to identify and describe the regulatory requirements for medical devices. The student knows and can use relevant standards, guidelines and methods. The student will be able to communicate and report results.