Our client, a market leader in in-vitro diagnostics, has a broad portfolio of devices in immunodiagnostics, transfusion medicine and clinical chemistry analyzers. To maintain its leadership position in the EU region, the client needed to ensure that all its product lines are IVDR compliant within the May 2022 deadline. Through a highly structured approach to remediation, process automation and in depth understanding of the new regulations, we developed technical documents in accordance to Annex I, Annex II and Annex III of IVDR.
Our solution helped the client to ensure IVDR readiness for multiple products within a period of 18 months, way ahead of the May 2022 deadline. Download the case study to learn more.
