Medical Device Software Development Summit Europe 2025
Description
Dedicated to shedding light on the intricate layers of European regulation, integrated cybersecurity features and forecasted uncertainties around AI, the 2nd Medical Device Software Development Summit Europe served as a pivotal platform to better align software innovation with compliance.
Highlights
Dedicated to unraveling European and global regulations for medical device software. Mitigating vulnerabilities in security and managing updates to legacy devices. Sharing case studies and best practices in advancing and maintaining compliance of innovative software. Addressing the integration of AI and ML into software development and associated regulatory challenges. Implementing best practices to streamline documentation processes and balance efficiency with regulatory requirements. Building a Software Bill of Materials for Embedded Packages, Open Source & Third-Party Software to meet FDA requirements. Identifying and isolating pivotal deliverables outlined in the SPDF guidance. Exploring how AI in QMS can help meet compliance and improve efficiency. Fostering cross-functional collaboration to align Agile methodologies with enhanced product compliance. Discussing cybersecurity across the total product lifecycle.
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