Benchmark & Fuse Knowledge from Software, QA, RA & Product Teams to Align Innovation in Software with Evolving Processes, Cybersecurity, & Global Regulatory Frameworks in New & Legacy Devices
Companies Already Confirmed to Attend:
Welcome to the 5th Annual Medical Device Software Development Summit 2025
The global digital health market is set to reach a staggering $660 billion in 2025, growing at a compound annual growth rate of 15.1% from 2020. As demand for cutting-edge medical devices like AI-powered diagnostics, connected diagnostic imaging systems, and remote patient monitoring devices accelerates, manufacturers must navigate a rapidly evolving landscape. With the FDA's AI guidelines and changing cybersecurity standards, ensuring compliance while balancing speed to market and robust security measures has never been more urgent.
Dedicated to navigating the complexities of US and global regulations, addressing cybersecurity vulnerabilities, and managing legacy device updates, the 5th Medical Device Software Development Summit unites industry leaders - from medical device giants to innovative start-ups - to explore actionable strategies, share best practices, and collaborate on solutions for ensuring the continuous compliance and security of cutting-edge software in a rapidly evolving market.
Unlock strategies to build resilient AI-cybersecurity frameworks amid regulatory uncertainty. Olympus and Retina AI will reveal how to secure AI-driven medical devices, integrate cybersecurity into development, and stay ahead of evolving compliance demands.
Streamline global regulatory submissions across the FDA, EU, Japan, and beyond. Leaders from AbbVie and Analog Devices will share strategies to navigate complex approvals, harmonize multi-region submissions, and overcome cross-jurisdictional challenges with confidence.
Future-proof legacy medical devices while ensuring global compliance. Werfen will unveil strategies to mitigate cybersecurity risks, address regulatory gaps, and modernize outdated software systems.
Master SBOM integration and change control for global regulatory compliance. Straumann Group will share best practices for ensuring traceability, managing post-market software changes, and navigating regional regulatory differences.
Harness the potential of closed-loop AI systems for dynamic healthcare environments. Convatec will delve into the challenges of building and deploying AI models that continuously adapt through real-time data feedback, ensuring safety, performance, and regulatory compliance throughout the lifecycle.
Eleanora Chakraborty
Associate Director, Regulatory Affairs, Strategic Global Labeling, Combination Products & Devices
Abbvie
What 2024 Attendees Found Valuable:
“Hot topics, high calibre of speakers, and great depth of conversation” Associate Director, Emerging Technologies Regulatory & Quality Lead, Biogen
"The conference exceeded all of my expectations. The diverse formats, and state-of-art topics were engaging and educational. I was extremely fortunate to have made the time to attend the full conference” Vice President, VisCardia
“This event gives insights into the concerns of other medical device companies and their strategies for addressing them” Research, Algorithm & Artificial Intelligence Engineer, Phillips
“There were brilliant people who attended, and they were all willing to share their experiences that will be very helpful to take back to our corporate teams” Senior Lead, Global Regulatory Affairs, Software & Cybersecurity, Fresenius
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