Medical Device Regulatory Affairs: A Practical Workshop

A one-day deep dive into the fast-evolving world of medical device regulation. Organized under the umbrella of Swiss Medtech Romandie with the support of Lucendra and CVCI, this workshop brings together practical insights on EU MDR, FDA pathways, and the growing impact of digital health and AI. Designed for both start-ups and established MedTech companies, it offers concrete tools to navigate regulatory complexity and accelerate market access in Switzerland, Europe, and beyond.

Language: 
- Bilingual format - English & French
- Questions welcome in English, French or German

Speakers: 
- Linda Ahnen, Principal Consultant at Lucendra
- Kim Rochat, Senior Partner at Lucendra 
- Jurjen Zoethout, Senior Partner at Lucendra and an Innosuisse Special Coach 
- Nicolas Durand, President of the Advisory Board of SwissMedTech Romandie

Lucendra is a Swiss MedTech consulting company providing agile, pragmatic support to start-ups, SMEs, and strategic companies. The company specializes in Quality, Regulatory, Clinical, Scientific, and Digital Health services for medical devices, including in vitro diagnostics, combination products, implantable and substance-based devices, software, AI/ML-enabled, and wearable devices across all risk classes. Support spans the entire device lifecycle, from early development and regulatory strategy to verification, validation, clinical evidence, approval, and market launch.

Registration required, places are limited.

Agenda