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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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
Synopsis
- 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