BSI Innovation Day: The Startup Journey to Compliance

BSI Innovation Day: The Startup Journey to Compliance

📅 Date: 16 October 2025

📍 Location: HYPERION Hotel Basel, Messeplatz 12, CH-4058 Basel, Switzerland

Navigating Compliance for Emerging MedTech Innovations

BSI Innovation Day brings together regulatory experts, industry leaders, and HealthTech innovators to provide strategic guidance on MedTech regulatory compliance and market access. This event is tailored to help startups developing Software as a Medical Device (SaMD) and AI-driven healthcare solutions successfully navigate the evolving EU MedTech regulatory landscape.

Why Attend?

Innovative startups face increasing complexity in MedTech regulatory compliance. This event will focus on:

• Support MedTech Innovation in Compliance – Providing regulatory pathways and market access strategies.
• Comprehensive Understanding and tailored approaches of SaMD, QMS & AI Regulations – Explore key compliance requirements, including clinical evaluation, risk management, cybersecurity, and software lifecycle management.
• Engage in Structured Dialogue – Facilitating open discussions to bridge regulatory knowledge gaps and promote collaboration between startups and Notified Bodies.

Who Should Attend?

🎯 Startup Founders, Product Managers, Regulatory Leads & Developers specializing in SaMD and AI-driven medical technologies.

💡 Investors, Incubators & Innovation Hubs supporting the growth and development of early-stage MedTech companies.

Agenda:

• Keynote Presentations – BSI’s Industry leaders and regulatory experts share insights on navigating MedTech compliance.
• Interactive Structured Dialogue Sessions – Direct engagement with regulators to clarify expectations and address compliance concerns.
• Network with Industry Peers – Connect with like-minded startups and key stakeholders in the HealthTech ecosystem.

This event will foster knowledge-sharing, collaboration, and actionable insights to support startups in achieving regulatory compliance and successful market entry.

📢 Register now and take the next step in your MedTech Startup journey!

Any questions regarding this event? Please contact Ferdinando Lamagna (Marketing Manager Medical Devices EMEA) at RmVyZGluYW5kbyAhIExhbWFnbmEgfCBic2lncm91cCAhIGNvbQ== or Marjolein van Diest (Marketing Executive Benelux & Nordics) at TWFyam9sZWluICEgdmFuRGllc3QgfCBic2lncm91cCAhIGNvbQ==

Participation Fee

To attend this exclusive event, we kindly request a participation fee of 50EUR for startups & 100 EUR for ecosystem stakeholders.

Info: Structured dialogue is a great tool to further help understand your notified bodies expectations and bring predictability to your submission. This session will help you understand the scope of structured dialogue, how a meeting is typically held alongside some key information on what you can and cannot ask your notified body.

Info: QMS basics for Start-up Companies: minimum requirements for initial ISO 13485 certification and common pitfalls in the QMS implementation.

Info: A high level overview, what needs to be included, what do manufacturers be careful/aware about or common pitfalls

Also check out other Meetups in Basel.