Workshop : Defining the Borders with Lucendra|Medtech Consulting

Biopôle is delighted to partner with Lucendra|Medtech Consulting on the following workshop:

Defining the Borders: Precision Medicine, Medical Devices, Wellness, and Software as a Medical Device — A Global Regulatory Perspective.

This interactive workshop will focus on the boundaries between innovation and regulation in precision medicine, wellness, and software-based healthcare solutions, and provide a global overview of current and upcoming regulatory expectations.

On Thursday November 20, 2025, Lucendra will focus on the following topics:

• Understanding when personalized medicine solutions qualify as medical devices under EU and US regulations.
• Distinguishing between wellness products and regulated medical devices and identifying key risk and claim thresholds.
• Gaining insight into the latest EU, US, and Middle Eastern regulatory updates shaping the 2026 compliance landscape.

The format will be: center around the sharing of practical experiences and fostering a comprehensive understanding of the current regulatory landscape.

The targeted audience is: for MedTech and healthcare professionals, including those in R&D, Regulatory Affairs, Quality Assurance, Clinical Operations, and Senior Leadership roles such as CEOs and COOs.

Agenda:

• 12.00: Welcome
• 12h15 Personalized Medicine: RUO or In-Vitro Diagnostic Medical Device?
• 12h30 The Wellness-Device Dilemma
• 12h45 Global Regulatory Outlook 2026: EU, US and Middle East
• 13h00 Q&A and Apéro
• 13h30 End

Speakers:

• Rima Padovani

Rima is a senior regulatory professional with RAC (Devices) certification and over 10 years of experience in the medical device field. As a Principal Consultant at Lucendra, Rima helps clients navigate strategic regulatory activities for medical devices and IVDs, including AIMDs, brain electrodes, cardiovascular devices, ATMPs, combination products, and ensuring regulatory compliance in Europe and the U.S.

• Linda Ahnen

Linda 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.

• Jurjen Zoethout

Jurjen 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.

About Lucendra|Medtech Consulting

Lucendra is a Swiss-based full-service MedTech consulting firm based at Biopôle, 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.

Access to Biopôle

By public transport

Take the M2 metro line to the Croisettes terminus. The Alanine 5A building is within walking distance from the station.

By car

Parking is available at the P+R Vennes car park. From there, you can take the M2 metro to Croisettes, or walk uphill (about 5 minutes) to reach Alanine 5A.