Date: 6-8 October, 2026
Location: Virtual
Introduction:
During DIA’s virtual workshop, Medical Devices and Drug-Device Combination Products: Post-Market Surveillance and Clinical Evidence, taking place from 6–8 October 2026, Qserve’s Bianca Lutters will host a specialist session.
The three-day workshop will bring together Notified Body and industry experts to explore how Post-Market Surveillance (PMS), clinical evidence and risk management interact throughout the lifecycle of medical devices and drug-device combination products. Through expert presentations, real-world case studies and interactive discussions, participants will gain practical guidance on establishing and maintaining an effective PMS system.
On 6 October at 14:30 CEST, Bianca will present:
Introduction to Risk Management: Interfaces with PMS and PMCF
Her session will address ISO 14971, production and post-production activities, the interaction between safety-relevant information and the risk management process, and the standardization of interfaces between risk management and PMS.
Participants will gain a clearer understanding of how post-market information should feed back into risk management and how these connected processes support continued device safety, performance and regulatory compliance.
About the workshop
The workshop specifically focuses on medical devices used with drugs or biologics to support or deliver medicinal products. Participants will learn how to apply PMS requirements under the EU MDR and other relevant frameworks, connect PMS with clinical evidence and risk management, implement effective safety-reporting systems, and address the challenges associated with connected drug-device combination products.
The programme is designed for professionals working in Post-Market Surveillance, pharmacovigilance, device safety, Regulatory Affairs, Clinical Affairs, Digital Health and Quality Assurance.
For more details, and the full agenda, visit the event website.
Virtual workshop
06 October 2026