What Happened at the 6th Medical Device Software Development Summit in 2026?
The Definitive Forum for Medical Device Software, AI & Regulatory Excellence
Medical device software entered a new era, and 2026 proved to be a tipping point. AI was no longer experimental, cybersecurity was no longer optional, and regulators were no longer patient. FDA scrutiny, EU MDR realities, the EU AI Act, and rising post-market expectations reshaped how software was built, validated, and sustained. The old model of siloed engineering, quality, and regulatory teams simply did not hold.
The 6th Medical Device Software Development Summit was where the industry recalibrated. This was the only dedicated forum bringing together the senior leaders responsible for designing, approving, and securing AI-enabled medical software, from Software Engineering and Digital Quality to Regulatory Affairs, Product, and Cybersecurity.
Over three high-impact days and immersive workshops, attendees explored how to:
- Turn regulatory change into competitive advantage
- Govern adaptive and AI-driven systems with confidence
- Build audit-ready CI/CD and automation pipelines
- Embed cybersecurity and quality into every release
- Align technical decisions with evidence, reimbursement, and long-term market success
This was a working summit for decision-makers shaping the future of regulated software. For organizations building, validating, or overseeing medical device software, this was where strategy sharpened, partnerships formed, and 2026 was defined.
Event Highlights
Systems-thinking Simulation Workshop, Designing Agentic AI for Regulated Medical Software
In this interactive systems-thinking workshop, attendees designed and stress-tested AI agents across engineering, V&V, regulatory, and cybersecurity lenses to define guardrails, oversight models, and governance strategies for deployment.
With Expert Insights From:
- Ephrat Most, Software Quality Program Director, Medtronic
- Timothy Hanson, Vice President – QA & Regulatory Affairs, Etiometry
Fishbowl Debate on Assistive vs. Autonomous AI: Where Should Humans Stay in the Loop?
This interactive debate brings together senior leaders to examine how assistive, decision-support, and autonomous AI shift risk, validation, and regulatory positioning. Explore models for “human in the loop,” “on the loop,” and supervisory control, and leave with clarity on aligning autonomy with safety and compliance expectations.
With Expert Insights From:
- Shreya Sridhar, Principal Systems Engineer, Medtronic
- Ephrat Most, Software Quality Program Director, Medtronic
- Sucheth Koppa, Head of Software V&V, Roche
- Michael Iglesias, Digital Health Engineering & Quality, Merck
- Mark Daly, Chief Technology Officer, Digital Diagnostics
Deep Dive into Navigating Global Regulatory Expectations for Software and AI Enabled Devices
As global regulatory expectations evolve, software teams must rethink submission strategy, traceability, and post-market change management. Attendees heard how leading regulatory experts are adapting to tightening FDA scrutiny, EU MDR realities, and emerging EU AI Act requirements.
With Expert Insights From:
- Abhineet Johri, Regulatory Affairs Quality Assurance, Professional, Siemens Healthineers
Expert Presentation on Managing SOUP & Open-Source Risk in Medical Device Software
As open-source and third-party components become embedded in device architectures, governance must be proactive. This session explored meeting SOUP requirements, maintaining audit-ready SBOMs, implementing risk scoring and vulnerability monitoring, and building a scalable framework for third-party oversight.
What Was New
Improving Cross-Functional Alignment to Accelerate Regulated Software Delivery
Misalignment between engineering, quality, and regulatory teams remains one of the biggest hidden causes of delay in medical device software. This session explored where breakdowns typically occur, how to translate design controls into engineering-friendly workflows, and how to implement shared ownership models for risk and evidence.
Heard From:
- Shreya Sridhar, Principal Systems Engineer, Medtronic
Aligning Software Decisions with Market Access & Commercial Viability
Software, regulatory, and product decisions now directly influence reimbursement, intended use positioning, and long-term market sustainability. This session explored how organizations are aligning lifecycle updates, evidence strategy, and commercial timelines from day one, ensuring technical architecture decisions strengthen, rather than delay, market access.
Heard From:
- Tanvi Gupta, Product Manager, Takeda
- John Beebe, Software Quality & Cybersecurity Manager, Velico Medical
- Saloni Shah, Compliance Lead & Engineer, ResMed
Case Study: Scaling Down Big-Company Approaches for Startup Frameworks
In this real-world case study, attendees discovered how structured quality and engineering systems were simplified without losing regulatory rigor, and examine the trade-offs startups face when selecting specialized tools and workflows. Included audience Q&A to explore how strategies scale across company sizes.
Heard From:
- John Beebe, Software Quality & Cybersecurity Manager, Velico Medical
Regulatory Implications of AI & Code Generation in Medical Device Software Development
This session broke down how to verify AI-assisted outputs, manage tool reliability and versioning, and implement governance frameworks that keep AI-generated software testable, auditable, and compliant, without stifling productivity.
Heard From:
- Gerald Rigdon, Fellow in Software Engineering / R&D (Active Implantable Systems), Boston Scientific
Explore the Previous Event Guide
- 75+ 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 70+ senior decision-makers
Attending Companies Included
Explore the Previous 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.