From Code to Compliance: AI Across the Software as a Medical Device (SaMD) Lifecycle

Thursday, September 18, 2025

12:00 PM

-

01:00 PM

Online

Host

RJ Kedziora

Co-Founder/COO Estenda Solutions

Join us for a focused, expert-led session that explores how artificial intelligence can transform every stage of the Software as a Medical Device (SaMD) lifecycle from initial planning to post-market monitoring. This event will equip you with practical insights to leverage AI effectively while ensuring safety, quality, and regulatory compliance.


What You’ll Learn:

  1. Understand the Role of AI in Each Phase of the SaMD Lifecycle
    Discover how AI can be applied to planning, development, testing, validation, deployment, and post-market monitoring to optimize processes and outcomes.

  2. Identify Opportunities to Improve Efficiency and Quality Using AI Tools
    Explore actionable strategies and tools to accelerate timelines, enhance code quality, and improve documentation and traceability across your SaMD projects.

  3. Recognize the Risks and Regulatory Considerations of AI-Driven Development
    Gain a clear understanding of potential pitfalls, ethical concerns, and compliance challenges when integrating AI into regulated digital health software workflows.


Whether you are a developer, quality assurance professional, regulatory expert, or digital health innovator, this session will provide the knowledge you need to navigate the intersection of AI, safety, and compliance in the medical device space.