FDA & Foreign Regulatory Affairs

Standalone Module - Spring 2026 - 4 ETCS - CHF 4'200

  

In this module participants will learn to navigate through foreign regulatory frameworks. The module provides an overview of the global regulatory landscape and current developments, including practical applications and best practices. The module in particular covers an introduction to the US FDA regulatory infrastructure and framework, with a focus on the expectations in pre-market submissions, including the different types of medical device submission pathways.  

Learning objectives

  • You acquire a high-level understanding of the global regulatory landscape including harmonization efforts,
  • You are able to evaluate foreign legislation and regulations to ensure compliance with regulatory requirements and understands the roles of the various regulatory agencies and the regulatory framework in selected countries,
  • You develop a fundamental understanding of how to navigate through and apply the US FDA regulations governing medical devices,
  • You understand the different submission document types for US market access and can submit an application compliant to US FDA device regulations,
  • You are able to draft a pre-submission packet and prepare for a pre-submission meeting,
  • You understand the interdependency of regulatory and business considerations.

Scope & duration

4 ECTS points
This is equivalent to roughly 100-120 working hours

Start

The module takes place in spring term each year.
On-site (in-person) events for the upcoming spring term: 

  • 29.04.2026 (9-3pm) - Kickoff 
  • 12.06.2026 (9-5pm) - Wrap up and presentation

📍On-site events take place at sitem-insel in Bern, Switzerland.

In between those onsite events you will have weekly assignments, such as reading, writing, presentation or short online webinars.
These dates might be subject to change. Please feel free to contact the School if you have any more detailed questions. 

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.