OVERVIEW

5th Medical Devices & SaMD: AI, Regulatory and Compliance is organized by Vonlanthen Group of Companies and will be held from Nov 20 - 21, 2025 at, Berlin, Germany.

Description:
Join industry experts at the 5th Medical Devices & SaMD Summit on 20–21 November 2025 in Berlin. Gain practical insights into MDR, IVDR, FDA, and the upcoming AI Act. Master SaMD development from design to approval, align your QMS with IEC 62304 and ISO standards, and apply risk management across the lifecycle. Learn how to meet AI transparency rules, cybersecurity regulations, and streamline submissions with automation. Network with peers across software, compliance, and product development

Key Practical Learning Points

Stay up to date on global regulations: EU MDR, IVDR, FDA, and the evolving AI Act for medical technologies.
Understand the full lifecycle of SaMD development: from design control and software architecture to regulatory approval.
Learn how to align your Quality Management System (QMS) and technical documentation with AI and software-specific standards (IEC 62304, ISO 14971, ISO 13485).
Apply risk management principles across the development lifecycle using real-world examples and engineer-driven workflows.
Navigate PMCF strategies, SSCP requirements, and clinical evaluation reports to maintain compliance under MDR.
Understand the classification of AI-powered medical devices, how to meet transparency and bias requirements, and prepare for conformity assessments.
Build secure, connected devices that meet cybersecurity regulations and integrate data privacy by design.
Learn strategies to streamline regulatory submissions through automation, structured data, and AI-assisted clinical evaluations.
Address challenges with combination products, borderline classifications, and notified body feedback.
Exchange best practices with peers in software engineering, regulatory strategy, and product development during interactive sessions and panels.