Anna Säfström
Clinical Project Manager / Clinical Research Associate
Aurevia
Sweden
Anna Säfström, MSc Biomedicine, is a Clinical Project Manager and Clinical Research Associate at Aurevia with a proven track record in managing clinical studies within the medical device and in vitro diagnostic sectors. Anna is skilled in leading studies across multiple European sites and coordinating cross-functional study teams. She is experienced in all stages of the study lifecycle — from planning and initiation through conduct with monitoring, and oversight — ensuring that all aspects of the study are conducted according to the study plan, regulatory requirements (MDR/IVDR), and applicable standards (ISO 14155/ISO20916) to maintain compliance, data integrity, and participant safety.
Topics
Designing and Executing an IVD Clinical Performance Study
Clinical Evidence Generation
IVD
5.2.2026 14:10 - 14:50 | Hall 209
This presentation provides a practical overview of how to plan, design, and conduct an in vitro diagnostic (IVD) clinical performance study under the EU In Vitro Diagnostic Regulation (IVDR). It covers key regulatory expectations, operational planning, and execution with monitoring and safety reporting. All which are of outmost importance to generate robust clinical evidence that supports IVD conformity assessment and market access.