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Josefin Jakobsson

Regulatory/Medical Writing/Start-up Manager
Aurevia
Sweden

Josefin Jakobsson is a Regulatory, Medical Writing, and Start-up Manager at Aurevia, a company with highly qualified QA/RA and clinical research professionals. With extensive experience across the medtech sector, both in the industry and as a consultant, Josefin has worked broadly with medical devices including clinical investigations/performance studies, clinical evaluations, vigilance, and risk management. Josefin has deep expertise in MDR and IVDR, particularly in the design and execution of clinical investigations and performance studies within the EU regulatory framework. As a trained MSc-level engineer and PhD, Josefin combines scientific rigor with practical regulatory insight. Josefin finds great satisfaction in guiding manufactures with their clinical development strategies while helping them navigate regulatory requirements and ensure quality assurance.

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.