Why Attend the Only European Summit Dedicated to Medical Device Software Development?

Europe's medical technology market is now worth more than €170 billion, while the global Software as a Medical Device (SaMD) market is forecast to grow at over 37% CAGR through 2031, creating unprecedented opportunities for software-driven innovation.

As AI accelerates development and regulatory expectations evolve across MDR, the AI Act and cybersecurity frameworks, software, quality, regulatory and product teams must work together more closely than ever before.

Join Europe's only dedicated Medical Device Software Development Summit to benchmark AI adoption, navigate regulatory change and learn how leading MedTech organisations are bringing innovative software products to market faster, safer and with greater confidence.

Audience - 4th Medical Device Software Development Europe

What's New for 2026?

78% New Speaker Faculty

61% AI-Focused Case Studies

8+ New MedTech Companies Speaking

4+ New Interactive Session Formals

1 AI-Dedicated Workshop Day

Unmissable Event Highlights

Implement Human-in-the-Loop AI Governance to Increase Development Efficiency While Maintaining Regulatory Confidence

Discover how to establish practical oversight, validation and review processes that enable teams to leverage AI productively while maintaining traceability, accountability and patient safety.

Philips logo - 4th Medical Device Software Development Europe

Accelerate AI-Driven Software Development to Improve Productivity, Quality & Workforce Efficiency

Explore how to deploy AI across documentation, software development and quality workflows to reduce manual effort, empower teams and scale adoption responsibly.

Roche logo - 4th Medical Device Software Development Europe

Stay Ahead of Evolving AI Regulations to Reduce Uncertainty & Build Confidence in AI Adoption

Gain practical insight into translating emerging AI Act requirements, global guidance and evolving regulatory expectations into actionable development strategies that support long-term compliance.

3shape logo - 4th Medical Device Software Development Europe

Harness Internal AI Agents to Streamline Product Security & Strengthen Regulatory Readiness

See how to use internal AI agents to improve product security activities, support software development teams and accelerate innovation while maintaining compliance and governance controls.

Edwards Lifesciences logo - 4th Medical Device Software Development Europe

Reduce Regulatory Complexity Across MDR, AI Act & Cybersecurity Requirements to Accelerate Market Readiness

Benchmark strategies for building integrated compliance frameworks that avoid over-compliance, improve traceability and enable faster software development and regulatory submissions.

Straumann logo - 4th Medical Device Software Development Europe

Strengthen Post-Market Surveillance Programmes to Improve AI Oversight & Reduce Regulatory Risk

Hear directly how to improve signal detection, navigate emerging AI monitoring challenges and integrate cybersecurity incidents into effective post-market surveillance frameworks

MHRA logo - 4th Medical Device Software Development Europe

Explore the Full Event Guide

  • Discover how leading MedTech teams are using AI today to accelerate software development, improve quality and reduce development burden
  • Benchmark your AI, software and compliance strategy against Philips, Edwards, Straumann, Elekta, Roche and other industry leaders
  • Explore practical approaches to navigating MDR, AI Act and cybersecurity requirements while accelerating market readiness
  • Learn how 14+ organisations are building trusted, scalable AI programmes through stronger governance, validation frameworks and real-world implementation lessons
  • Access 16+ implementation-focused case studies, debates and interactive discussions designed to help you solve today's software development challenges, not tomorrow's
2nd Operationalize Expanded Access Programs - Full Event Guide

Attending Companies Include

Audience - 4th Medical Device Software Development Europe

Explore the Agenda

Gain practical insights from Roche, Philips, Edwards Lifesciences, Huma, MHRA and more as they share real-world experiences deploying AI, strengthening compliance and bringing innovative software to market faster

Partnership - 4th Medical Device Software Development Europe

Partner With Us

Position your solution at the centre of conversations around AI adoption, software quality, cybersecurity, compliance and development efficiency with Europe's medical device software leaders.

Experts - 4th Medical Device Software Development Europe

Join Biopharma Experts

Exchange ideas, benchmark your strategy and build valuable relationships through workshops, roundtables, debates and networking sessions designed specifically for the medical device software community.