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Training Objectives
• Get an overview of the regulatory landscape and regulatory stakeholders in MedTech
• Understand the major principles, concepts and processes
• Learn to sequence the necessary steps and build awareness of possible pitfalls when bringing a MedTech product to the market
• Know where and how to find required information
Target Audience
• Researchers in the field of translational medicine
• Employees from spin-offs, start-ups and SMEs, who intend to bring a product to the market
• Employees from companies interested in getting an overview on regulatory affairs
• Investors in MedTech who would like to understand risks and opportunities regarding the evolving regulatory frameworks in EU and US
Prerequisites
• Affinity to or involvement in MedTech or Life Sciences
• Basic understanding of good practices in product development and innovation
• Technical / scientific background or commercial background linked to Life Sciences products
Program – 20th of January 2026
09.00 Welcome
Danielle Spichiger, Head Life Sciences, Business & Economic Development, Canton of Zurich
Dr. Urs Zuber, Head Industry Relations, ETH Zurich
Dietmar Schaffarczyk, Abteilung Wissenschaftliche Integrität und Forschungsethik & D-HEST, ETH Zurich
09.20 – 10.45 Introduction EU/US Regulatory Frameworks
• Legislation on Medical Devices
• Stakeholders
• Pathways to Market
10.45 – 11.00 Coffee Break
11.00 – 12.00 Business Case – Time to Market
• Group work / Presentation
12.00 – 13.00 Lunch Break
13.00 – 14.45 Design & Development
• Design verification and pre-clinical verification
• From user requirements to clinical validation
14.45 – 15.00 Coffee Break
15.00 – 16.00 Business Case – Clinical Evidence
• Group Work / Presentation
16.00 – 16.45 Start-up & Regulatory – Avoiding Pitfalls
• Milestones of a medical device innovation project, a different view
16.45 – 17.00 Wrap Up & Closing Words
Organizer
Business and Economic Development (AWI), Canton of Zurich
ETH Zurich Industry Relations
Life Science Zurich Business Network
Partner
Lucendra | Medtech Consulting
Lucendra is a Swiss-based full-service MedTech consulting firm based in Switzerland, providing agile and pragmatic support to start-ups, SMEs, and strategic companies. We deliver tailored Quality, Regulatory, Clinical, and Scientific services for medical devices, including in vitro diagnostics, combination products, implantable, substance-based devices, software, digital health, and wearables across all risk levels. Our expertise covers every stage of the device lifecycle: design, development, verification, validation, regulatory approval, manufacturing, and launch.
Speakers
Jurjen Zoethout is a seasoned MedTech expert with over 25 years of experience in the medical device industry. As a Senior Partner at Lucendra, he focuses on guiding clients through complex regulatory,
quality, and clinical landscapes. His deep expertise in EU and US requirements regulations enables companies to efficiently navigate compliance pathways and bring their innovative technologies to market.
Linda Ahnen is a physicist with a PhD in Biomedical Engineering and RAC (Devices) certification. As a Principal Consultant at Lucendra, with over five years of experience in Regulatory and Clinical Affairs,
specializing in clinical strategies, regulatory pathways, and technical documentation for CE and FDA submissions, Linda supports innovative MedTech projects from early development through to compliance.

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