Description This Solutions Circle invites participants to openly discuss common challenges in managing regulatory-compliant technical documentation without unnecessary complexity. Guided by real-world experiences across MDR, IVDR, SaMD, and AI-based medical devices, you will exchange best practices on reducing redundancies, improving traceability, and streamlining approval workflows. We'll focus on practical, data-driven approaches to digital documentation, including structured data models, end-to-end traceability, and realistic AI support. Leave with peer-tested insights and concrete ideas you can apply to move from document-heavy processes toward sustainable, digitally enabled regulatory compliance.
Learning Objectives:
Identify and articulate common technical documentation challenges related to traceability gaps, redundancies, and fragmented approval processes.
Compare peer approaches for managing regulatory documentation using structured data, digital workflows, and automation.
Evaluate practical, real-world uses of digital tools and AI in regulatory documentation and distinguish effective practices from unrealistic expectations.
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