8:00 am Registration & Morning Refreshments

8:50 am Chairperson’s Opening Remarks

Balancing Regulatory Compliance with MDR Innovation

9:00 am Navigating UK Medical Device Software Regulations Since Brexit

  • Fariborz Karimi Regulatory Affairs Specialist, Johnson & Johnson Services, Inc


  • Examining we know so far about UK MDR and its implications on medical device software development and route to market
  • Exploring the future framework for software medical device regulations in the UK

9:30 am Effective Strategies for Software Requirement Analysis in Alignment with IEC 62304


  • Distinguishing the various requirements outlined in IEC 62304
  • Investigating diverse sources of requirements, including regulatory, risk management and cybersecurity aspects
  • Crafting verifiable requirements and striking the optimal balance in quantity
  • Exploring Agile maintenance of requirements

Building a Robust Framework for Responsible & Effective Medical Device Software Development & Deployment

10:00 am A Practical Framework for Secure Medical Software Development Lifecycle: Best Practices, Standards & Guidelines


  • Crafting a practical framework that seamlessly integrates cybersecurity activities into the product development cycle, tailored for corporate, agile, and regulated environments
  • Delving deeper into critical areas like vulnerability management, threat modelling, and risk assessment
  • Sharing insights and lessons learned from our journey in design and implementation – aspects of automation, the structure of documentation, clarity on roles and responsibilities, and the indispensable tools that support these processes

10:30 am Speed Networking Session


Join our speed networking session tailored for medical device software experts, like yourselves, to connect with industry peers and catalyse the exchange insights & expertise.

11:00 am Morning Break & Networking

11:30 am Understanding Usability Issues: Risk Management Approach for Software Medical Devices


  • Discussing the applicability of ISO 14971 for software risk management and the differences between SaMD, SiMD and MDSW
  • Highlighting challenged associated with software usability
  • Understanding software risk management and control measures
  • Intersection between usability and MDR requirements

12:00 pm Navigating Medical device privacy compliance in the digital age


  • Illuminating the Upcoming privacy related EU regulations for medical device software development 
  • Discussing how to successfully leverage your current privacy program
  • Exploring the role of the agile privacy professional

12:30 pm Panel Discussion: Optimizing User Experiences & Human Factor Integration

  • Igor Menghini Senior Director, Medical Devices & Algorithms Software, Roche Diagnostics GmbH
  • Dr. Shaloo Sood Team Leader RDI Academy, Institut Straumann


  • Delving into the distinct and shared hurdles of each domain.
  • Unravelling strategies to effectively merge these functions
  • Assessing the potential for cross-team collaboration to enhance resource allocation
  • Evaluating the feasibility of integrating research and evaluation tasks for efficient gain
  • Strategizing how to incorporate UX and human factors early in the process for quicker and more profound insights

1:00 pm Roundtable Discussion: Securing Medical Devices: The DevSevOps Journey


  • Discovering how Development Security Operations (DevSecOps) streamlines software delivery by ingraining security into the software engineering process from the outset
  • Unveiling the strategy of achieving higher software security levels with fewer cybersecurity experts through the democratization of cybersecurity responsibilities.
  • Emphasizing that DevSecOps entails both technical and cultural transformation in your entire R&D organization, aligning with pioneering Lean, Agile and DevOps Methodologies

1:30 pm Lunch Break & Networking

Enhancing Product Marketability by Improving Software Design

2:30 pm Roundtable Discussion: Balancing R&D Efficiency & Configuration Traceability to Ensure Reproducible Results

  • François Peter Senior Director of Software Engineering, GE Healthcare
  • Lionel MARTY Senior Manager, Lead Biogen Digital Health SaMD Technology, Biogen


  • Exploring strategies to streamline R&D processes, fostering efficiency without compromising quality.
  • Delve into the essentials of configuration traceability, discussing frameworks and methodologies for reproducible outcomes
  • Navigating the delicate equilibrium between R&D efficiency and traceability, drawing insights from real-world success stories and innovative approaches

3:00 pm Innovative Approaches to Post-Market Surveillance

  • Tauseef Mehrali Vice President of Medical Safety & Regulatory Affairs, Ada Health
  • Andreia Pimenta Clinical Evaluation & Surveillance Manager, Ada Health


  • Understanding essential responsibilities concerning post-market surveillance in compliance with MDR
  • Exploring the use of RWD to meet the new PMS requirements set by the MDR
  • Exploring the use and challenges of new technologies (e.g. LLMs) which can not only enhance the product but also streamline and innovate processes

3:30 pm Afternoon Networking Break

4:00 pm Unveiling the Digital Frontier: Navigating Challenges in Software Strategy & Development

  • Jean Chaoui Vice President of Clinical Applications and Solutions, Digital, Robotics and Enabling Technologies, Stryker Corp.


  • Exploring the intersection of software strategy and development in robotics, delving into the dynamic landscape of digital technologies
  • Navigating the complexities of robotic systems, focusing on key aspects such as autonomous navigation and cutting-edge enabling technologies
  • Addressing challenges spanning from conceptualisation and architecture to regulatory approval, highlighting the role of quality processes and agile frameworks in achieving success

4:30 pm Roundtable: Tools of the Trade: Unveiling Strategies from Industry Leaders to Optimize Software Development

  • Robert Krejci Senior Software Engineering Manager, BD Technologies


  • Gaining invaluable knowledge from industry leaders as they reveal the top tools employed through the software development timeline, empowering you with insights to elevate your practices
  • Exploring a curated selection of tools endorsed by leaders, learning how their strategic use enhances efficiency, collaboration, and innovation across various stages of software development
  • Discovering how leveraging specific software can be a game-changer in optimizing your software development process, propelling your projects to new heights of productivity and success

5:00 pm Chairperson’s Closing Remarks

5:10 pm End of Conference Day One