Medical Device Seminar Series 2026 - Quality Management Systems in Medical Technology: Certification, Design, Security and Strategy
Registration is now open for QMS Day 2026, part of the Medical Device Seminar Series 2026!
Join us for QMS Day 2026 – Quality Management Systems in Medical Technology: Certification, Design, Security, and Strategy, an on-site short course organised by Ghent University.
QMS Day brings together regulatory professionals, engineers, start-ups, SMEs and master’s students for a one-day deep dive into quality management systems in the medical device and connected technology sectors.
The programme will explore:
🔹 How to approach a QMS as a management system, beyond a compliance checkbox
🔹 Lessons from an ISO 13485 certification journey
🔹 Designing medical software and hardware under MDR and EURATOM requirements
🔹 Integrating ISO 13485 and ISO 27001 within one management system
🔹 How company structure and organisation can influence the effectiveness of a QMS
🔹 How a Notified Body assesses a QMS during ISO 13485 and MDR audits
🔹 The relationship between quality management systems for medical devices and clinical trials
Through real-world examples and case-based discussions, participants will gain a clearer understanding of common compliance challenges and effective strategies for building scalable and compliant quality systems.
Master’s students, regulatory affairs professionals, QA/RA managers and MedTech founders are welcome to join.
The NoBoCap project is co-funded by the European Union through the EU4Health programme.