Description Explore how regulatory-compliant technical documentation can be managed without unnecessary complexity. Drawing on more than a decade of experience across MDR, IVDR, SaMD, and AI-based medical devices, we'll address common pain points such as redundant content, missing traceability, fragmented approvals, and inefficient document-centric workflows. You'll be introduced to a practical, data-driven approach to digital documentation using structured data models, end-to-end traceability, automated workflows, and realistic AI support. Real-world examples from startups, established manufacturers, and notified bodies illustrate how digital approaches can reduce time to certification, improve compliance quality, and support continuous regulatory readiness.
Learning Objectives:
Identify common technical documentation inefficiencies and compliance risks arising from document-centric and manual processes.
Explain how structured data models, traceability, and automated workflows improve regulatory compliance and audit readiness.
Assess the realistic capabilities and limitations of AI in regulatory documentation and apply pragmatic criteria for its responsible use.
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