A France-based client approached Freyr for preparing Scientific Validity Reports (SVRs) for 11 IVDs, in order to submit to the Notified Bodies. With a huge market portfolio of IVD diagnostic products in the EU, the client was in the process of updating the IFUs of the already marketed diagnostic products and the scientific validity section of Performance Evaluation Report (PER) was yet to be updated for IVDR compliance.
To know, how Freyr assisted the client to submit high-quality SVRs (11 in number) to the Notified Bodies, in a short span of one (1) month, download the proven case.
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