Conference Day 1
7:40 am Check in & Coffee
8:25 am Chair’s Opening Remarks
Addressing the Rapidly Evolving Cybersecurity Regulations to Ensure Medical Devices Remain Compliant
8:30 am Navigating Medical Device Cybersecurity & the Product Lifecycle to Optimize Processes for Future Regulatory Changes
Synopsis
- Harmonizing Regulatory Compliance and Cybersecurity to ensure smooth adaptation to evolving standards
- Implementing an effective medical device cybersecurity risk management program following least burdensome principles
- Leveraging cybersecurity frameworks to accelerate the clearance or approval process for medical device
9:00 am Roundtable: Navigating The Width and Depth of Transparency Required When Making SBOM (Software Bill of Materials) Submissions to Ensure Validation of Medical Devices
Synopsis
- Streamlining the process of fully disclosing all software components, including third-party libraries and open-source elements
- Discussing how detailed SBOM submissions enable effective security management by identifying and addressing potential vulnerabilities
- Explaining the role of transparent SBOM documentation in facilitating regulatory adherence, ensuring thorough traceability of components
9:45 am Leveraging Periodic Post-Marketing Checks to Ensure Devices in Market Remain Compliant & Secure
Synopsis
- Reassessing the growing threat surface around this device from the time the device was launched into market
- Implementing continuous monitoring systems to ensure ongoing compliance and security of medical devices post-market
- Integrating post-market surveillance with 510(k) requirements to maintain FDA compliance through effective post-market evaluations
10:15 am Speed Networking
Synopsis
This session is the ideal opportunity to shake hands with many of the experts securing and futureproofing
new and legacy devices to establish meaningful business relationships
10:45 am Morning Break & Networking
11:15 am What Does Good Look Like to Ensure Cybersecurity Compliance on a Global Scale for Current & To Be Expected Regulations
Synopsis
- Current guidelines and the challenges behind implementing them
- How can you constantly be on top evolving regulations?
- Lessons learnt from previous experiences and how to stay ahead of the curve
11:45 am Leveraging Regulatory Affairs from the Initial Stages of Device Development to Ensure Regulatory Compliance & Speed to Market
Synopsis
- Implementing comprehensive procedures early in device development to align with regulatory requirements and streamline approval processes
- Best practices for incorporating Regulatory Affairs partners from project kick-off to mitigate risk and optimize time to market
- Addressing potential regulatory hurdles proactively during initial stages to facilitate smoother device development and regulatory approval
12:15 pm Lunch & Networking
Navigating Novel Challenges Brought By AI to Bullet-Proof Security Against Future Risk
1:15 pm Enabling Cybersecurity Solutions for Robust Security Enablement
Synopsis
- Importance of application security tools and its relevance when in collaboration with product security
- Consolidating application security findings into one centralized pane of glass to understand the context of application risk
- The involvement of AI in cybersecurity and ways by which cybersecurity needs to evolve to remain robust and compliant
1:45 pm Panel: Consolidating the Definition of AI Under the Context of Cybersecurity to Ensure Accurate Compliance of The New Generation Medical Devices
Synopsis
- Establishing clear definitions and classifications of AI within cybersecurity frameworks to ensure consistent understanding and application
- Aligning AI definitions and applications with existing regulatory standards and guidelines
- Promoting educational initiatives among stakeholders about AI’s role in cybersecurity, fostering a unified approach to compliance and risk management
14:30 pm Afternoon Break & Networking
3:00 pm Cybersecurity Considerations for AI/ML Medical Devices
Synopsis
- Challenges of AI/ML compared to traditional software
- How AI/ML complicates security
- Overview of resources and current standards projects that are closing this knowledge gap
3:30 pm Building Cybersecurity Frameworks for Autonomous AI/ML Medical Devices
Synopsis
- Understanding how to build cybersecurity into AI/ML medical devices
- Challenges with embedded AI/ML systems within medical devices
- Regulatory expectations for cybersecurity of AI/ML medical devices