The customer is a leading manufacturer of In-Vitro Diagnostics (IVDs) dedicated to revolutionizing microbiology laboratory products. The customer’s entire products were FDA cleared and CE marked under the EU IVDD. Currently, the customer has a huge product portfolio and needs a timely transition from IVDD to IVDR. However, the customer was facing challenges in grasping the intricate requirements of IVDR (2017/746) and ensuring accurate interpretation. Additionally, there was overhauling existing data collection, documentation, and reporting processes to match IVDR requirements.
Therefore, the customer approached Freyr for assistance with performing a systemic literature review and preparing compliant reports for their huge portfolio of IVDs products. How did Freyr provide high quality deliverables within the given timeframe? What were the customer benefits? Read through this proven case.
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