As the FDA finalized updated guidance on cybersecurity, the integration of AI and ML into software development raised more questions than answers, and gold standard software development becomes outdated more and more quickly, it has never been more critical to stay ahead of the curve.

The Medical Device Software Development Summit 2024 offered invaluable insights for navigating the intricacies of the highly regulated and fiercely competitive medical device sector. Tailored to alleviate the challenges of balancing R&D innovation with regulatory compliance, this summit united industry Key Opinion Leaders to share their diversified knowledge over this comprehensive 3-day program. Dedicated to interrogating crucial topics such as risk management, (cyber)security, submission pitfalls, compliance, global harmonization and PCCPs, this event also covered:

• Exploring how AI in QMS can help to meet compliance along with improving efficiency.
• Implementing best practices to streamline documentation processes, striking the right balance between efficiency and satisfying regulatory requirements, ultimately saving valuable time.
• Building out a Software Bill of Materials for Embedded Packages, Open Source & Third-Party Software to Meet FDA Requirements and Ensure Regulatory Approval.
• Identifying and isolating pivotal deliverables outlined in the expansive SPDF guidance, simplifying the document for a more digestible and actionable understanding.

Over 120 industry experts from esteemed organizations like Insulet, Abbott, Medtronic, GE Healthcare, Philips, and others attended as they uncovered practical strategies to align Agile methodologies, enhanced product compliance, and fostered cross-functional collaboration, contributing to an industry-wide effort to balance robust regulations with fast-paced innovations.