Case Study: Division of the world’s leading health care company achieves MDR compliance, 50% shorter review cycles and 15% translation savings with RWS

Consultative approach to IFU verification and optimization goes beyond translation to ensure MDR compliance and audit readiness

A division of the world’s leading health care company for dialysis, hospitals and outpatient care faced a growing need to update and translate a large volume of Instructions for Use (IFUs) to meet EU Medical Device Regulation (MDR) requirements. Long in‑country review cycles, inconsistent terminology and costly translations across 20+ languages threatened time to market, compliance and audit readiness.

RWS provided a consultative, ISO‑certified solution—adding MDR compliance verification, IFU optimization, a move from Word to FrameMaker, centralized translation memories and a dedicated native‑language team plus DTP and in‑country review guidance. The work cut review cycles by 50%, reduced translation budgets by 15% through TM centralization, shortened IFUs by 25% (lowering translation and printing costs), and improved MDR compliance, audit readiness, consistency and user experience.