The customer is a leading manufacturer of In-Vitro Diagnostics (IVDs) and biomedical testing, specialized in healthcare. The customer’s products were CE marked as per IVDD and already marketed in the EU. Currently, the customer is looking for a transition towards IVDR 2017/746. However, the customer was facing challenges maintaining consistency in clinical reports across different sections and years, while accommodating changes and updates, according to the EU-IVDR. Additionally, the customer required additional research to identify and address the gaps in data collection or reporting and had an unavailability of clinical data on some indications/use.

Therefore, the customer approached Freyr for assistance with preparing compliant annual clinical reports for their huge portfolio of IVDs products. How did Freyr provide high quality deliverable within the given timeframe? What were the customer benefits? Read through this proven case.