About this Case Study
The case study involved updating the Technical File documentation for more than
100 IVD products according to Regulation (EU) 2017/746.
The company faced the high impact of the new IVD Regulation; firstly for the products that need additional clinical data and also the ones where the classification changed.
To learn more about the successful project and the comprehensive results achieved, download the full case study now.
Discover the step-by-step process, key improvements, and valuable insights that allowed the company to update to the new IVD regulation.