Webinar: AI in Software Development: Benefits, Risks, and Cybersecurity Considerations
Synopsis
This webinar explores the evolving role of Artificial Intelligence in medical device software development, examining both the significant benefits and inherent risks. It delves into the cybersecurity implications of integrating AI into these critical systems, highlighting the unique challenges and vulnerabilities that arise. The discussion will cover strategies for secure AI implementation and maintaining the integrity of AI-driven medical technologies. This session aims to provide a clear understanding of how AI transforms the development landscape and the necessary cybersecurity precautions to ensure patient safety and data privacy.
Key takeaways
- Understand the advantages of using AI in medical device software development.
- Identify specific cybersecurity risks introduced by AI in medical devices.
- Learn about frameworks and standards relevant to AI in medical devices (e.g., ISO 14971 for risk management, IEC 62304 for software lifecycle processes, and potentially FDA guidance on AI/ML-based SaMD).
- Explore strategies for securing AI models and data within medical devices.
- Discuss the importance of transparency and explainability in AI for medical device regulatory compliance.
- Gain insights into pre-market and post-market cybersecurity considerations for AI-driven medical devices, including SBOM/VEX for transparency.
- Learn best practices for integrating AI securely throughout the software development lifecycle.
- Consider the impact of AI on regulatory submissions like eSTAR and how to address AI-specific concerns in documentation.
Get FDA cleared without the cybersecurity headaches.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.