Case Study: a leading diagnostics manufacturer achieves IVDR compliance and 30% cost reduction with FREYR

Leading Diagnostics Manufacturer delivers 215 CPRs and cuts costs 30% with FREYR

A leading diagnostics manufacturer faced the challenge of transitioning its large portfolio of in vitro diagnostic products from IVDD to the new IVDR regulation. With internal capacity stretched thin, meeting stringent IVDR timelines was difficult. The company engaged FREYR for regulatory support to manage extensive data mining, a complex product portfolio, and stakeholders across multiple geographies.

FREYR implemented an agile execution strategy, forming a dedicated global team to deliver the project in waves. This approach efficiently accommodated the ad-hoc addition of new products into scope. FREYR delivered over 400 robust regulatory deliverables, including Clinical Performance Reports and State-of-the-Art reports, ensuring full compliance ahead of schedule. The solution provided a 30% reduction in project costs for the customer while maintaining complete transparency.