Conference Day One
8:00 am Registration & Coffee
8:50 am Chair’s Remarks
Safeguarding Healthcare: Fortifying Security in Medical Device Software Development
9:00 am Exploring Challenges & Solutions in Preventing Data Poisoning & Corruption in Medical Device Software Development
Synopsis
- Implementing rigorous validation processes and advanced algorithms to detect and mitigate potential risks, ensuring the reliability of medical device software for accurate diagnoses and dosage calculations
- Integrating proactive compliance monitoring mechanisms and adopting a transparent development approach to meet and exceed regulatory standards, thereby preventing intentional data corruption and ensuring lawful market access
9:30 am Discussing Supply Chain Risk Management & its Implementation within the Medical Device Quality Management System
Synopsis
- Exploring effective strategies for managing diverse suppliers within the medical device Quality Management System, ensuring a comprehensive and holistic approach
- Discussing methods for conducting thorough security reviews of suppliers, emphasizing the importance of robust practices to safeguard the integrity of the supply chain
- Delving into key areas to consider before, during, and after the design phase, offering insights into critical decision points to bolster supply chain resilience
- Highlighting essential steps at various stages of the product development lifecycle, providing actionable guidance for navigating the intricacies of supply chain risk management throughout the entire process
10:00 am Ensuring Cloud Security & Regulatory Compliance: Strategies for Monitoring & Testing
Synopsis
- Deploying comprehensive monitoring systems and rigorous testing protocols to ensure the security of cloud services, safeguarding the integrity of your product against potential threats
- Proactively monitoring and testing cloud services to guarantee compliance with industry regulations, preventing legal implications and ensuring a seamless path to market
- Prioritizing the implementation of advanced security measures, continuous testing, and collaboration with regulatory bodies to establish a resilient framework that protects cloud services
10:30 am Morning Break & Networking
Synopsis
Join our speed networking session tailored for medical device software experts, like yourselves, to connect with industry peers & facilitating rapid yet meaningful exchanges of insights & expertise. Elevate your networking experience during this session designed for impactful connections within the space of medical device software development
11:30 am Understanding the FDA Cybersecurity Final Guidance
Synopsis
- Considering the statutory changes driving the regulations
- Grasping Secure Product Development Framework (SPDF) concepts
- Identifying FDA submission deliverables and discussing scalability
12:00 pm Navigating Remote Services: A Comprehensive Approach to Security & Compliance
Synopsis
- Exploring robust controls implemented in remote services, addressing both security and regulatory requirements
- Discussing proactive measures used to address user concerns
- Exploring real-world examples illustrating the diversity of solutions used within Siemens Healthcare to mitigate these challenges, with a focus on improving security and compliance
12:30 pm Roundtable Discussion: Transition of Security Risk to Patient Risk: From a Security Standpoint
Synopsis
- Exploring the challenges arising from implementing the guidance documents to better understand what potential risk you should mitigate and at what level
- Elucidating the risk management process 49 71 expectations to highlight practical applications of the process
- Explaining how to approach these common challenges from a testing perspective
1:00 pm Lunch Break & Networking
Mastering Regulations: Unveiling Insights for Streamlines Development, Swift Approvals & Market Success
2:00 pm Best Practises for Streamlining Your Documentation Process to Save Time Whilst Complying with Regulatory Requirements
Synopsis
- Implementing best practices to streamline documentation processes, striking the right balance between efficiency and satisfying regulatory requirements, ultimately saving valuable time
- Delving into the challenges associated with validating changes for audits, offering insights and strategies to overcome hurdles and maintain compliance in a dynamic regulatory landscape
- Highlighting the benefits of tools like Confluence and GitHub for tracking documentation, and suggesting opportunities for enhanced documentation when needed, ensuring a cohesive and organized approach to regulatory compliance
2:30 pm Roundtable Discussion: Building out a Software Bill of Materials for Embedded Packages, Open Source & Third-Party Software to Meet FDA Requirements & Ensure Regulatory Approval
Synopsis
- Addressing the vague regulatory expectations regarding the quantity of tangible elements required in the software Bill of Materials, and exploring strategies to meet these expectations without compromising efficiency
- Clarifying FDA expectations on showcasing direct and/or transitive dependencies within software composition analysis, with a focus on identifying the optimal levels of dependencies needed to satisfy regulatory requirements and ensure efficient use of time and talent
- Exploring the intricacies of vulnerability scans in the assessment of vulnerabilities in open source and third-party software packages
3:00 pm Afternoon Break & Networking
3:30 pm Navigating Build-Test-Learn Cycles in a Regulated Environment to Balance Innovation & Compliance
Synopsis
- Discussing the challenges of incorporating build-test-learn cycles in a regulated environment
- Highlighting the importance of bringing agile methodologies to the medical device industry, emphasizing the need to adapt to the real-world complexity and messiness while still meeting regulatory expectations
- Collaborating to demonstrate how different functions can work together to buildtest-learn in a compliant manner
4:00 pm Keeping Up with Evolving Guidance & Regulations Related to Software Development
Synopsis
- Cultivating a culture of continuous learning within software development teams to stay ahead of evolving guidance and regulations, fostering adaptability and proactive compliance measures
- Emphasizing the importance of collaboration between software developers and regulatory experts, enabling effective interpretation and implementation of evolving regulations while ensuring alignment with industry standards
- Exploring the role of technology, automation, and documentation management systems in monitoring and ensuring compliance with dynamic regulatory landscapes, facilitating efficient adaptation to evolving requirements
4:30 pm Closing Remarks
4:40 pm Medical Device Software Development Poster Session:
Synopsis
This poster session is your go-to session to obtain competitive insights and present your most innovative work to medical device thought leaders and decision-makers. For more information or to submit your abstract, please email info@hansonwade.com