Connecting Software, QA, RA & Product Teams to Benchmark AI Integration, Balance Innovation, Compliance, & Safety, & Accelerate Speed to Market
Medical device software development is entering a new era. Advances in AI are enabling smaller, highly specialised teams to achieve what once required entire departments, accelerating everything from software development and testing to documentation and quality processes. Yet while the technology is evolving rapidly, many organisations are still determining how AI can be implemented safely, validated effectively and governed responsibly within regulated environments.
For European MedTech organisations, this challenge is amplified by an increasingly complex regulatory landscape. As MDR interpretation continues to evolve, the AI Act begins to reshape expectations for AI-enabled products, and cybersecurity requirements grow in importance; software, regulatory, quality and engineering teams must work together more closely than ever before. Success now depends on balancing development speed with compliance, automation with oversight, and innovation with patient safety.
The 4th Medical Device Software Development Summit Europe brings together software, regulatory, quality, cybersecurity and engineering leaders to share practical lessons from the front line of AI adoption. Through implementation-focused case studies, peer benchmarking, interactive discussions and a candid debate, attendees will explore how leading European and global MedTech organisations are accelerating development, strengthening governance, improving regulatory readiness and bringing innovative products to market with confidence.
Because the question facing Europe's medical device software community is no longer whether AI will transform development. It is how to harness it responsibly, navigate evolving regulatory expectations and deliver better products faster while maintaining trust with regulators, customers and patients.
“Much of what makes medical software succeed in the real world happens after regulatory clearance - in deployment, operations and the relationship with hospital IT. I value this summit for the candid, peer-to-peer exchange on exactly those topics, which rarely make it into guidance documents or standards.”
Jelle Reichert, Chief Technology Officer, WARD 24/7
“Attending the summit will give valuable insights into how Medical Device manufacturers are adopting AI in software development while maintaining regulatory compliance and product safety. The agenda offers practical perspectives on AI validation, cybersecurity and evolving MDR/AI Act requirements. It is also a great opportunity to benchmark internal practices, learn from industry experts, and build professional connections.”
Morten Cramer, Head of Hardware & Software, InnoCon Medical
"I look forward to gaining practical, up-to-date insights into MDR, the AI Act and cybersecurity requirements, and learning from notified bodies and industry peers. I am particularly interested in how medical device software development can be made more efficient - with and without AI - while maintaining compliance, and in deepening my understanding of cybersecurity requirements and best practices.”
Päivi Turta, Director - Quality & Regulatory Compliance Quality, Medbase
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
Attending Companies Include
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
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.
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.