Blog

Ethical and regulatory clearance – Clinical validation takes longer than you think!

The new IVDR transitional periods that have been published in January 2022 took some pressure from all of us who still need …

Prospective clinical performance studies – Worth the effort?

In the IVDR-era, clinical performance studies have gained much importance. In fact, this expensive but necessary step in IVD-development is one of the most broadly …

Careful with the terms ‘prospective’ and ‘retrospective’ – Are you referring to study design or sample procurement?

In this article, we would just like to raise awareness for a terminology issue which is prone to cause …

Sample size calculation – Is there an easy way out?

We have all learned a lot about clinical performance studies for IVD validation in the past couple of years: With thousands of Covid tests entering the EU-market …

Targeted sample procurement – What is it and why is it needed?

When planning a clinical performance study, the most conspicuous limiting factor is the availability of samples.