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Tackling performance requirements in the more prescriptive world of IVDR

About this episode

IVD manufacturers must perform two types of performance studies, clinical performance and analytical performance, in order to provide evidence that the device is safe and performs as intended.
While both have always been required, IVDR is a lot more prescriptive.

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.