IVDR IVDD Changes

Proposed changes to IVDR transitional arrangements.

The Covid pandemic has seen some significant disruption in the release and adaptation of new (and revised) regulatory requirements globally. None mores so than the release of MDR and IVDR. We thought we would share some proposed amendments to the IVDR (Regulation EU 2017/746) around transitional arrangements moving from IVDD (Directive 98/79/EC). The intent is…

Make use of Usability. How to get it right… and wrong.

In the medical device world, Usability Engineering (IEC62366 The application of Usability Engineering or its 60601 counterpart IEC60601-1-6) is a required tool within the validation of a medical device. Regardless of if it’s, software, active, or IDV, Usability engineering helps us understand how the device (or system) react within a real-world application. It draws from the…