The Regulatory ‘Tsunami Wave’ Approaches: An ISC22 Conversation
Enhance your success in bringing new in vitro diagnostic (IVD) devices to market or conducting clinical trials for medical devices and pharmaceuticals utilizing IVD technology. Join renowned industry expert, Kimberly Oleson, May 23 and 25, 2023 for a comprehensive exploration of the global regulatory landscape governing IVD devices. https://www.aami.org/training/trainin...
Innovators are often unaware or unprepared for the full extent of regulatory changes, even years after they’re initially announced. One example is new European regulations for in vitro diagnostics, the EU’s IVDR. Kimberly Oleson, founder and principal consultant for Lucent Clinical Consulting, sat down in the AAMI Studio to discuss this and more.