The need to strengthen the regulatory platform across the European Union (EU) is driven by the need to ensure patient safety and device performance. The new Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) regulations seek to harmonize the regulations to improve transparency and product traceability.
Regulatory changes are an effective step towards enabling the Intelligent Industry. Capgemini helps organizations transition smoothly to the new EU
MDR/IVDR requirements by offering a customized strategic approach, from gap assessment to lifecycle management support.