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.

More specifically, we will talk about:

• Understanding when personalised 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.

TARGET AUDIENCE

This workshop is tailored 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

SPEAKERS