3rd Annual Global Medical Device Safety & Quality Summit

Key facts

Date: 1 — 2 October, 2026

Place: Berlin

Conference Overview

The Global Medical Device Safety & Quality Summit is a senior-level, international summit bringing together leaders from medical device manufacturers, notified bodies, regulatory authorities, and healthcare organisations to examine how safety and quality can be sustained and strengthened across the entire device lifecycle.

As regulatory expectations increase and technologies evolve, the industry faces growing pressure to ensure robust quality systems, effective risk management, and reliable post-market oversight while continuing to support innovation and patient outcomes. This summit provides a structured platform for open dialogue on practical approaches to safety assurance, quality excellence, and operational resilience in a complex global environment.

Through expert-led presentations, case studies, and panel discussions, participants will explore best practices in quality management, vigilance and post-market surveillance, clinical performance, supplier oversight, and organisational accountability. The programme is designed to encourage knowledge exchange between established regulatory frameworks and emerging industry practices, enabling organisations to maintain trust, consistency, and high performance.

By fostering meaningful engagement between stakeholders responsible for safety and quality, the Global Medical Device Safety & Quality Summit supports the industry’s shared responsibility to protect patients while delivering dependable, high-quality medical technologies worldwide.

Key topics

Human Factors Engineering & User-Centric Safety Design – Ensuring safe, intuitive, and error-resistant devices through robust usability engineering practices.
Cybersecurity for Modern & Legacy Medical Devices – Threat modelling, secure development practices, and strategies for elevating cyber resilience across device portfolios.
Software as a Medical Device (SaMD) & Digital Health Compliance – Lifecycle requirements, cloud adoption, interoperability, and validation frameworks for connected systems.
The Future of Medical Device Innovation & Global Compliance – Forward-looking insights on AI, digital ecosystems, regulatory convergence, and the next 5 years of MedTech governance.
Quality-by-Design & Reliability Across the Device Lifecycle – Building durable, safe, and compliant devices through proactive quality engineering from concept to market.
Strengthening Quality Management Systems Across the Device Lifecycle – Ensuring consistency, control, and accountability from design and manufacturing through post-market activities.
Risk Management Excellence: From Hazard Identification to Clinical Performance – Practical approaches to integrating ISO 14971 risk management with real-world clinical and safety data.
Quality and Safety Challenges in Legacy Devices and Portfolio Management – Maintaining compliance, performance, and safety for long-standing products under evolving regulatory scrutiny.
Human Factors, Usability, and Patient Safety Outcomes – Reducing use-related risks through design, usability engineering, and post-market feedback integration.
Preparing for the EU AI Act in Medical Devices – Practical implications for high-risk AI systems, documentation, transparency, and integration with MDR requirements.