2023 In-Vitro Diagnostics Products Technical File Update

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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.

Rephine provided the
knowledge and expertise
that enabled IVD products
to be certified under the
IVDR regulation in Europe in
record time. 

Download the Case Study

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