Our representatives during the BKWM Conference

It was an intense but very valuable time. This week, the delegation from MDR Regulator and Pure Clinical participated in the 2nd National Conference dedicated to clinical trials of medical devices.

MDR Regulator is pleased to announce its participation in the 2nd edition of the National Conference dedicated to clinical trials of medical devices and the performance testing of in vitro diagnostic devices. The event titled “CLINICAL TESTS OF MEDICAL DEVICES” gathered experts and specialists from across the industry.

Katarzyna Wesołowska, a board member of MDR Regulator and Pure Clinical, shared her knowledge on topics related to preclinical studies and preparatory actions before the commencement of clinical trials. She discussed the impact of the AI ACT on clinical trials of medical software and the use of the European medical database EHDS to train algorithms with retrospective data. “This is a high-level conference that facilitates valuable discussions with representatives from regulatory bodies, Notified Bodies, medical device manufacturers, CROs, and clinical centers,” Wesołowska stated.

Agnieszka Czajkowska from MDR Regulator also emphasized the importance of often overlooked yet crucial aspects of preparing medical devices for clinical trials. She highlighted the challenges faced by manufacturers during the research phase, underscoring the conference’s role in addressing these key industry issues.