Event info
Date:23 Apr, 2025
Time:9:30 - 16:00
Venue:Danneskiold-Samsøes Allé, Copenhagen
25% discount for MVA members

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Contact person

EXTERNAL EVENT

Ellen De Bever
Ellen@healthtechhub.org

BSI Innovation Day: The Health Tech Startup Journey to Compliance

Navigating Compliance for Emerging Health Tech Innovations
BSI Innovation Day unites regulatory experts, industry leaders, and HealthTech innovators to provide strategic guidance on MedTech compliance and market access. Tailored for startups developing Software as a Medical Device (SaMD) and AI-driven healthcare solutions, this event helps navigate the evolving EU regulatory landscape.

Why Attend?
Regulatory Pathways & Market Access – Gain insights into compliance strategies for HealthTech startups.
SaMD, QMS & AI Regulations – Understand key requirements, including clinical evaluation, risk management, and cybersecurity.
Structured Dialogue – Engage directly with regulators to bridge knowledge gaps and foster collaboration.

Who Should Attend?
Startup Founders, Product Managers, Regulatory Leads & Developers in SaMD and AI-driven medical technologies.
Investors, Incubators & Innovation Hubs supporting early-stage MedTech companies.

Agenda Highlights
Keynotes – BSI experts share insights on MedTech compliance.
Interactive Sessions – Direct engagement with regulators to address compliance concerns.
Networking – Connect with startups and key stakeholders in HealthTech.
This event fosters collaboration, knowledge-sharing, and actionable insights to support regulatory success and market entry.

25% discount code: HealthTechHubCopenhagenBSI25

Date: 23 April 2025
Time: 9:30 – 16:00
Venue: Danneskiold-Samsøes Allé 41, 1434 København Ø.