Tackling Performance Requirements In The More Prescriptive World Of IVDR

IVD manufacturers are required to conduct two types of performance studies—clinical performance and analytical performance—to demonstrate the safety and intended functionality of the device. Although both have been obligatory, the IVDR imposes more stringent guidelines on these studies.

Speaker Bio: Keely So is Manager, Medical Devices / IVD at PharmaLex, leveraging her extensive knowledge of the regulatory requirements in Australia, Europe, New Zealand, the USA, Canada, and Asia to help clients with new product licensing and launch, regulatory impact and gap assessments, CE marking of devices and IVDs, ongoing product compliance initiatives and audit support.