Medical Device Clinical Evaluation

This module focuses on the clinical evaluation process and how such process is interrelated with other processes from the early design and development to post market phases to efficiently define the intended use and related clinical performance claims, establish the benefit risk profile of medical devices, and continuously monitor these aspects for optimal patient safety.

Learning objectives

• You understand the integrated process of clinical evaluation with other processes of the device lifecycle to optimize device design and related claims.
• You are enabled to position the device in the clinical context of the disease and evaluate regulatory requirements.
• You know how to translate safety and clinical performance claims and associated clinical benefits into objectives within the clinical evaluation process.
• You are able to determine what clinical data are necessary based on the benefit risk profile of the medical device.
• You can understand the full clinical evaluation/investigation processes and ensure outputs are effectively incorporated in the overall risk management and other processes.

Scope & duration

4 ECTS points
This is equivalent to roughly 100-120 working hours (incl. appr. 16-20 in person hours)

Start

The module takes place in fall term each year.

For next term, the module will be hold between 01.09.2026 and 18.10.2026.

You will have few on-site events and weekly assignments, such as reading, writing, presentation or short online webinars.
Please feel free to contact the School if you have any more detailed questions or are in need of exact dates.

Fee

This module can be attended as single course at a fee of CHF 4'200.-
👉 Contact the School if you are interested in this module as a single course.

Module leaders & lecturers