8:00 am Registration & Morning Refreshments

8:50 am Chairperson’s Opening Remarks

Artificial Intelligence Development & Compliance

9:00 am Developing, Deploying & Maintaining AI-based Products

  • Igor Menghini Senior Director, Medical Devices & Algorithms Software, Roche Diagnostics GmbH


  • Exploring the rise of AI-based methods in diagnostics and the unique challenges they pose in design, development, and regulation
  • Learning best practices and lessons spanning from concept to deployment and updates, emphasizing data selection, user experience and algorithm explainability
  • Gaining insights into the crucial role of regulatory considerations in ensuring safe and effective AI-driven diagnostic products for manufacturers, healthcare professionals and regulators alike

9:30 am AI Act – A New Era for Medical Devices


  • Navigating the upcoming AI Act from a medical device software perspective 
  • Highlights and challenges related to the regulation
  • Ensuring AI compliance in development and technical documentation 
  • Key takeaways to avoid regulatory roadblocks

10:00 am Morning Break and Networking

Adopting Agile Methodology to Streamline Software Development

11:00 am Combining Agile Methodology with Regulatory Compliance


  • Exploration of the regulation and harmonized standards that govern the area of SW development and deployment to gain an overview of what is required and permitted in terms of agile methodologies for MD software
  • Identification of what a notified body will expect to see in terms of processes at the SW manufacturer and what documentation is expected when software in the market is updated
  • Walkthrough a few examples to illustrate how the regulations and standards can be followed

11:30 am 6 Levels of Software Architecture Description to Establish Cross-Project Alignment in Mobile Applications SaMD projects


  • The role of the SW Architecture description as a tool to enable communication across SME areas (e.g., quality, regulatory, commercial, engineering, software) in an MDSW project
  • Establishing a SW Architecture description framework fit for purpose for Mobile Applications and Cloud-based SaMD development projects

12:00 pm Lunch Break and Networking

1:00 pm Panel Discussion: Empowering Quality: Shifting Left in Medical Device Software Development


  • Embracing the “shift-left” approach in medical device software development by prioritizing early and consistent testing for enhanced product quality
  • Integrating a culture of testing early and often to interactively enhance the development process and ensure robustness and compliance in medical device software
  • Strategically shifting left in the development lifecycle to optimize quality assurance and deliver safer and more reliable products

Expanding into the US Market & FDA Regulation

1:30 pm Between Two Continents: Comparing US and EU Cybersecurity


  • Exploring the varying regulatory requirements for SaMD cybersecurity in the US and EU, including a comparison of FDA guidelines and the EU regulation and guidelines
  • Discussing the latest cybersecurity threats facing SaMD, such as data breaches, ransomware attacks, and supply chain risks, and a comparison of how the US and EU are addressing these threats
  • Reviewing technologies and best practices being used to enhance SaMD cybersecurity in both the US and EU, including risk assessment methodologies, security testing frameworks, and regulatory guidance

2:00 pm Afternoon Coffee and Networking Break

2:30 pm Panel: How to Overcome the Different Regulatory Requirements to Maximize Your Chance of Successfully Introducing Your Product to the US Market


  • Exploring the nuanced differences between US and European regulatory landscapes, understanding their implications on innovation and safety for an informed market entry strategy
  • Uncover actionable insights to harmonise your approach, effectively addressing distinct requirements on both sides of the Atlantic and maximising the potential for successful product introduction
  • Learning how to balance innovation and safety considerations in your product development journey, ensuring compliance with diverse regulatory requirements for seamless entry into the competitive US Market

3:00 pm Speed Learning


In this quick fire 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!






3:30 pm Chairperson’s Closing Remarks

4:00 pm End of Conference