Identifying approaches and strategies for sustainability in medical devices Streamlining corporate sustainability ambitions into innovation and device development Identifying environmental impact drivers of medical devices and what are the main levers to improve device sustainability Shaping R&D and device ecodesign roadmaps to maximize sustainable return on investment (S-ROI) Selecting the right sustainability assessment tools and ecodesign approaches for effective implementation

Providing an overview of implementation timelines and focus the ISO 14155:2025 update Highlighting changes to risk management processes for clinical investigations, including their impact on AE reporting Discussing new requirements for suspension and termination of clinical investigations Addressing the impact of changes to statistical requirements Giving context to the estimand framework (ICH E9 (R1)) that is now referenced in Annex…

Streamlining product design iterations by leveraging AI for rapid prototyping and testing simulations Enhancing data accuracy and real-time monitoring in performance assessments through AI-powered analytics tools Predicting potential safety issues and design flaws using AI-driven risk management algorithms Automating regulatory reporting and compliance documentation with AI to reduce human error and delays

The scope of compliance explained with case studies The 7 hallmarks of an effective Corporate Compliance Program Organizational needs of a Corporate Compliance Program Potential synergies between quality and compliance

Transforming traditional R&D processes by integrating AI to enhance product development efficiency and accuracy Enhancing global quality standards through advanced analytics and machine learning algorithms for real-time monitoring Streamlining collaboration across interdisciplinary teams to foster innovative solutions tailored for patient needs Implementing rigorous testing protocols that leverage AI to predict product performance and reliability Driving continuous improvement initiatives by utilizing…

Emphasizing the ongoing importance of post-market surveillance for ensuring device safety and performance Analyzing how EU MDR and ISO 13485 shape the type, quality, and quantity of post-market data required Discussing strategies for effectively integrating regulatory requirements into operational workflows Identifying best practices for leveraging health data to enhance product performance and compliance

Enhancing image-guided interventions through advanced robotics Optimizing workflow efficiency in interventional suites and hybrid operating rooms with semi-autonomous robotic systems Towards bridging healthcare gaps through the deployment of autonomous and remote robotic technologies Pioneering the regulatory pathway for innovations in robotics and artificial intelligence in healthcare

How will emerging technologies shape the future of medical device design and production? Identifying which collaborations and partnerships will be essential for advancing the medical device industry in the coming years Looking at the role the new MDR and IVDR regulations will play on future innovations Exploring how medical device companies can leverage data analytics and real-world evidence to drive…

Enhancing decision-making by utilizing quantified benefit-risk assessments to drive patient-centric innovations Implementing data-driven methodologies to quantify benefit-risk throughout the device lifecycle for regulatory compliance Integrating real-world evidence to refine risk-benefit profiles, informing product development and market positioning Strengthening post-market surveillance by applying quantitative metrics to monitor device performance and safety Leveraging predictive analytics to anticipate potential risks and optimize patient…