Description: As medical devices evolve into complex, modular systems—often incorporating software components, AI/ML models, and third-party services—traditional compliance strategies are breaking down. Disconnected architectures and manual postmarket update processes are increasing regulatory risk, patient risk, and slowing innovation.
In this session, we’ll explore how AI-driven document orchestration can bridge traceability gaps, automate the generation and improve the quality of critical artifacts such as the Risk Management File (RMF), Post-Market Clinical Follow-up (PMCF), and Post-Market Surveillance (PMS) reports. We’ll demonstrate how modern systems can remain compliant with IEC 62304 and ISO 13485—even when reusing software components, evolving algorithms, or integrating AI tools.
Learning Objectives:
See how continuous traceability and validation can be maintained across a system-of-systems architecture, including evolving AI/ML components.
Identify practical strategies for maintaining alignment with IEC 62304 and ISO 13485 in dynamic, software-driven environments.
Explore real-world use cases demonstrating audit-ready automation and risk management across complex connected systems.
See how AI-driven document generation and orchestration tools can streamline the creation of compliant PMS, RMF, and PMCF documents.
