This week, the Pure Clinical delegation participated in the 2nd edition of the National Conference on clinical trials of medical devices and performance tests of in vitro diagnostic devices, under the theme “CLINICAL TRIALS OF MEDICAL DEVICES”.

It can be emphatically stated that in recent days, the Warsaw conference has been a key venue for discussing specific cases and the current challenges facing the medical device and IVD industry in Poland and Europe.

Izabela Chodara, Head of the Clinical Unit IVD at Pure Clinical, shared her insights: “The only constant in our industry is change—from changes in legislation to evolving guidelines concerning software and AI in the context of medical devices.”

It is worth noting that among the speakers were our experts Izabela Chodara from Pure Clinical and Katarzyna Wesołowska from MDR Regulator. They discussed the initial steps in designing a medical device and the preparation for testing IVD devices, providing valuable guidance on navigating the complexities of the industry.