Traverse Geopolitical Shifts & Regulatory Uncertainty, Spotlight AI Integration with Software, & Finetune the Balance of Compliance with Risk & Safety to Accelerate Speed-to-Market of Software-Based Devices
The 6th Medical Device Software Development Summit 2026 is the only dedicated forum built exclusively for leaders in Software, Quality, Regulatory, Cybersecurity and Product teams navigating the realities of regulated medical device software.
The market is shifting fast. FDA expectations for AI-enabled devices and lifecycle management continue to evolve, cybersecurity requirements are becoming more technically rigorous, and the EU AI Act alongside increasing global regulatory divergence is adding new layers of complexity. At the same time, AI innovation, code generation, automation, and continuous deployment are transforming how medical software is built, often faster than traditional compliance models can adapt. This Summit exists to bridge that gap, equipping software, quality, regulatory, and product leaders with the strategies needed to build compliant, secure, and future-ready medical device software in this new era.
Across 16+ deeply technical sessions and hands-on workshops, industry leaders will share real-world case studies, regulatory strategies, validation frameworks and implementation playbooks for AI, DevOps, cybersecurity architecture, documentation efficiency and global submission strategy. With an intimate audience of senior practitioners, discussions are practical, unfiltered and solution-driven, not theoretical.
If your team is building, validating or submitting software in 2026, this is where you will gain the clarity, peer insight and actionable strategies needed to reduce regulatory risk, accelerate approvals and confidently innovate in a rapidly shifting landscape.
What truly made this conference remarkable was the diversity of professional backgrounds among the attendees. Regulatory Affairs specialists, Product Managers, Engineers, Developers, and other stakeholders each brought unique perspectives to the table.
Cybersecurity Professional, Siemens Healthineers
Networking and sidebar discussions were excellent. The quality of presenters and attendees was stellar.
Distinguished Engineer, Medtronic
It was good to learn how other companies are working through the changes in cybersecurity regulations. I loved hearing about how ML/AI is being used in some products and how some of the regulatory changes for ML are now also changing how traditional devices are being evaluated.
Software & Electrical Engineering Manager, Boston Scientific Corporation
Explore the Full Event Guide
- 50+ Senior Industry Experts across Software, Regulatory, Quality, Cybersecurity & Product
- 19+ Technical Case Studies & Interactive Sessions from global MedTech leaders and innovators
- 3 Hands-On Pre-Conference Workshops with step-by-step implementation guidance
- 6 Core Content Themes covering AI, Regulatory Evolution, Cybersecurity, Lifecycle Quality & Commercial Strategy
- 6+ Hours of Dedicated Networking with an intimate audience of 50+ senior decision-makers
Your MedDevice Software Speaker Faculty
Attending Companies Include
Explore the Agenda
Dive into a content-rich program featuring 19+ sessions; case studies, interactive workshops, and cross-functional panels addressing AI governance, cybersecurity, validation strategy, and global regulatory change in medical device software.
Partner With Us
Position your organization alongside leading medtech and digital health innovators and ensure your solutions are front and center with the senior decision-makers reshaping compliant software development.
Join Biopharma Experts
Engage with senior engineering, regulatory, quality, and cybersecurity experts from global medtech and pharma companies, and build high-value connections during curated networking sessions designed for meaningful conversations, not surface-level exchanges.