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.

Module Leader and Lecturers

Regulatory Consultant

Cherry Malonzo Marty

Cherry Malonzo Marty is an MD and Biomedical Engineer by training. She has over 14 years of experience working in various functions in education, clinical settings, research, and regulatory affairs. She has co-authored the book chapter “Evolving Global Regulatory Landscape” in the 1st edition of The Combination Products Handbook published in 2023. Since 2019, she has been working as a regulatory writer and consultant for medical device and combination product submissions in the US and EU. Apart from her contracting projects, she currently works part-time as the Regulatory and Quality writer for a spin-off of ETH, Zürich.

Consultant Medical Device Regulatory Affairs MENA, APAC, LATAM

Annika Lörtscher

Annika Lörtscher is an experienced regulatory affairs professional and Senior Regulatory Affairs Manager with deep expertise in international medical device compliance and market access. She brings strategic insight into global regulatory landscapes and practical experience in navigating complex approval pathways. Annika is the owner of The Woman With The Hat, a consulting practice advising medtech companies on global regulatory pathways and market entry strategies.

Former Vice Director at Swiss Medtech, Medtech Expert

Daniel Delfosse

Daniel Delfosse is a senior medtech expert with deep experience at the intersection of regulatory affairs, innovation and industry strategy. After serving as Vice Director and Head of Regulation & Innovation at Swiss Medtech—where he championed medtech competitiveness and strategic regulatory engagement for years—he now leverages his expertise as a strategic advisor to startups and SMEs in the medical technology sector. Daniel combines technical training from ETH Zurich and a doctorate with a long career supporting innovation, market access and sustainable growth for emerging companies in regulated health industries.