This webinar explores how digitalization, automation, and artificial intelligence are reshaping Quality Management Systems (QMS) and Regulatory Affairs (RA) across the medical device and IVD lifecycle. Moving beyond a single-system perspective, the session demonstrates how AI-powered tools, eQMS platforms, software development tools, and intelligent regulatory data ecosystems can be integrated to streamline compliance, improve data quality, and enable scalable regulatory operations.
Participants will gain practical insight into how this new paradigm fits into a wider digital regulatory and quality landscape and support key processes such as UDI management, CER and PSUR generation, vigilance monitoring, and post-market surveillance, and how manufacturers can future-proof their organizations by adopting end-to-end digital solutions.
Topics:
- Digital Transformation of QMS & Regulatory Affairs
- From document-centric compliance to data-driven, intelligent QMS and RA ecosystems
- The role of AI, automation, and interoperability across the product lifecycle
- Regulatory compliance as a source of regulatory intelligence and business value
Digital and AI-Enabled Regulatory & Quality Operations
- AI-driven data validation, consistency checks, and error reduction
- Automation of regulatory workflows, submissions, and documentation
- Smart monitoring of regulatory updates, guidance changes, and data quality (AsphaSearch)
- Examples of Digital-powered platforms
Digital Platforms for QMS
- eQMS as a disruptive tool for modern quality management
- Comparison of digital QMS strategies: a side by side look.
- Case study: From paper to digital.
UDI & Product Data Management as a Digital Process
- Linking UDI, EUDAMED, and internal platforms.
- EUDAMED as one component of a broader digital RA architecture
- How EUDAMED modules work from a systems, data, and integration perspective (Aspha EudaMate)
- Key timelines and functional readiness toward 2026
Future Outlook
- How AI and digital tools will shape QMS and RA beyond 2026
- Preparing organizations for increased automation, AI governance, and interoperability via AI Act
- Moving from “compliance burden” to sustainable digital regulatory excellence
The webinar will last for approximately 1 hour, and there will be some time for Q&A at the end of the session.
Join Asphalion’s Medical Device Associate Manager, Diego Sanoja in this webinar!!
When? Thursday 19 February, 2026
Time: 3:00 – 4:00 p.m. CET
🔗 Register here: BARCELONA HEALTH INNOVATION WEEK ASPHALION
For further information, you can contact us at: [email protected]
