Pre-Conference Workshop Day
Tuesday June 24, 2025
8:00 am Check In & Coffee
Track One: Future-Proofing Medical
Devices: Advanced Cybersecurity &
Software Strategies
Track Two: Navigating Compliance in Medical Device Innovation
9:00 am Mastering the Technical Implementation of FDA Cybersecurity Regulations in Medical Device Software Development
Synopsis
- Bridging the gap between regulation and development by learning how leading companies are translating FDA cybersecurity regulations into actionable, technical development processes
- Integrating cybersecurity from the ground up by gaining practical insights into embedding security into the design and architecture of connected medical devices, ensuring robust protection at every stage of the device lifecycle
- Analyzing real-world case studies to discover how companies have overcome technical challenges in implementing FDA’s cybersecurity requirements. Examine examples of vulnerability management, patching, secure coding practices, and ensuring device security in complex healthcare environments
9:00 am Harmonizing Global Regulatory Strategies to Simplify Medical Device Submissions & Expand Market Reach
Synopsis
- Navigating complex regulatory landscapes across key global markets by discussing advanced strategies for interpreting and applying the regulatory requirements and submission processes for the FDA, EU, Japan, and other regions
- Harmonizing global submissions by gaining insights into streamlining regulatory submissions across multiple regions, minimizing redundancy, and optimizing time-to-market
- Managing cross-jurisdictional challenges by exploring common hurdles in managing multi-market regulatory approvals, including varying requirements for clinical trials, risk management, and post-market surveillance, and discovering strategies to overcome these challenges effectively
11:00 am Morning Break
12:00 pm Harnessing AI in Medical Device Software Development: Innovation, Efficiency & Ethical Boundaries
Synopsis
- How AI is currently integrated into medical device software development, including automation, validation, and regulatory considerations
- Examining AI-driven efficiency gains, cost reductions, and quality improvements, while addressing potential risks and compliance challenges
- Should AI be used in medical device software? To what extent, and how do we balance innovation with human oversight and ethical responsibility?
12:00 pm Building Practical AI Validation Frameworks in the Changing Regulatory Landscape
Synopsis
- Addressing best practices in AI development by exploring the key challenges in moving from high-level AI guidance documents to specific, actionable validation steps for medical devices, including strategies to integrate Predetermined Change Control Plans (PCCPs) to manage AI model updates effectively
- Developing software validation for AI-based medical devices by discussing how to establish robust software validation methodologies for AI applications
- Navigating the evolving regulatory landscape for AI by discussing how to prepare for future regulatory developments, including building systems that will allow your devices to evolve as new regulations and standards for AI are established
2:00 pm Lunch Break & Networking
3:00 pm Building Resilient AI-Cybersecurity Frameworks: Practical Strategies for Development teams Amid Regulatory Gaps
Synopsis
- Explore how development teams can proactively secure AI-driven medical devices, focusing on unique risks at the intersection of cybersecurity and AI when regulatory guidance is unclear
- Gain insights into structuring software development workflows to anticipate future cybersecurity and AI compliance requirements, ensuring systems are audit-ready without overengineering
3:00 pm Practical Insights into Regulatory Submissions & Documentation Best Practices for SaMD, SiMD, Digital Therapeutics & CDS
Synopsis
- Learning from industry peers by discussing real-world challenges and feedback encountered during regulatory submissions for various medical device categories
- Navigating essential documentation and plans by exploring the specific regulatory documentation and submission requirements for each type of medical device, including SaMD, SiMD, Digital Therapeutics, and CDS. Learn how to align these documents to regulatory standards while addressing the unique considerations of each device category
- Optimizing submissions across device categories by analyzing case studies of successful and failed submissions, focusing on the types of information critical for approval