Conference Day Two

8:00 am Registration & Coffee

8:50 am Opening Remarks

AI Insights: Navigating the Innovation Frontier & Aligning with Regulatory Expectations

9:00 am AI/ML Security: Navigating Offensively & Defensively Uses

  • Hasan Palaz Principal Cyber Security Architect, GE Healthcare


  • Exploring the dual nature of AI/ML tools and software, addressing both offensive and defensive perspectives from a security standpoint
  • Delving into the nuances of AI security and privacy, highlighting the potential dangers and challenges that arise when implementing AI/ML into medical devices
  • Discussing defensive strategies to protect against data breaches, restricted licenses, and privacy issues, with a focus on addressing these concerns early in the development process

9:30 am Implementing a PCCP and CI/CD for AI/ML-enabled Medical Devices


  • Learn a practical and systematic approach to designing, constructing, and validating a successful PCCP with examples of model creation, data training, bias assessment, testing, and best-in-class infrastructure.
  • Examine post-market ML software release processes that enable continuous validation in production including ingesting real-world data, modification protocols, and metrics for ML models.
  • Explore strategies for implementing CI/CD to fulfill a PCCP for a SaMD project to accelerate product release cycles 

10:00 am Leveraging Artificial Intelligence within QMS to Optimize Compliance for SaMD & SiMD Products


  • Exploring how AI in QMS can help to meet compliance along with improving efficiency
  • Discussing whether the regulations apply if we use AI within our QMS
  • Providing use cases will be around: OTS/SOUP, SBOM, Risk Management and keeping up with the regulations, and integration with the CICD pipeline

10:30 am Morning Break & Networking

11:30 am Panel Discussion: Where is AI Today & What is the Chance that Regulatory Bodies will Catch Up?

  • Stephen Odaibo CEO & Founder, RETINA-AI Health, Inc
  • Sabyasachi Roy Head of Regulatory Affairs - Enterprise Informatics, Innovation & Strategy, Philips
  • Chris Doherty Senior Lead Global Regulatory Affairs Software & Cybersecurity, Fresenius Medical Care North America


  • Examining the present landscape of AI and its applications, exploring the advancements and innovations shaping the technology today
  • Assessing the current regulatory landscape in relation to AI and potential challenges and opportunities in aligning regulations AI innovations
  • Considering potential strategies for achieving a harmonious relationship between AI advancements and regulatory oversight

12:00 pm Exploring AI Regulatory Requirements for FDA Submissions


  • Discussing the requirements, recommendations, and considerations for incorporating AI/ML expectations in legacy products
  • Highlighting how regulations and standards such as the EU AI Act may affect the approval of more traditional algorithms
  • Utilizing pre-submission programs to understand FDA expectations to stay ahead of new data requirements

12:30 pm Navigating the Impact of Generative AI on Medical Device Manufacturers


  • Exploring the challenges and opportunities that generative AI introduces to medical device manufacturers, including advancements in design and production efficiency
  • Discussing strategies for manufacturers to leverage this technology for enhanced innovation and efficiency
  • Addressing potential regulatory considerations when introducing generative AI into your medical device product development

1:00 pm Lunch Break & Networking

2:00 pm Exploring the Potential of Predetermined Change Control Plans (PCCP) in Medical Device Authorization


  • Exploring the legislation that enables companies to obtain FDA authorization for changes without requiring separate approvals
  • Seeking insights into the experiences of companies attempting to secure PCCP authorization and the potential benefits in terms of expedited modifications
  • Considering the guidance provided for AI/ML devices and exploring the broader applicability of PCCP across various types of medical devices

Innovation Integration: Bridging Agile Development and Transformative Education

2:30 pm Scaled Agile: Harmonizing between Traditional Product Teams


  • Exploring effective ways to bridge traditional long-term medical device innovations with agile deliveries
  • Evaluating strategies for running scaled agile with large sets of teams by exploring collaborative approaches for planning, executing, and releasing together
  • Delving into best practices from other organizations tackling similar challenges in scaled agile methodologies
  • Discussing potential adaptations and scaling up of the FDA TIR on agile to better align with industry needs and foster agile innovation

3:00 pm Afternoon Break & Networking

3:30 pm Fire-side Chat: Transforming Software Engineer Education for Industry Success

  • Sabyasachi Roy Head of Regulatory Affairs - Enterprise Informatics, Innovation & Strategy, Philips
  • Irvin Mangwiza Associate Director, Novo Nordisk


  • Establishing common success metrics for newly educated individuals entering the industry, including the creation of a measurement test and alignment on an idealized education
  • Exploring strategies to enable and empower the defined measurement criteria, ensuring educational programs align with industry expectations, and preparing talent effectively
  • Investigating methods to streamline the hiring process for medical device experts from universities and exploring time/ cost-effective mentorship models for achieving better hiring results

4:00 pm Speed Learning Session:


In this speed networking session, each table will feature a challenge discussed across the past three days. This is your chance to share final questions on these topics, and get insights from your fellow attendees that you can take back to the office to improve your processes right away!

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4:30 pm Closing Remarks

4:40 pm End of Conference