EUDAMED: Updated Rollout Plan for 2025-2027 Released The European Commission has released an updated EUDAMED rollout plan, introducing changes to the implementation timeline and transition periods. Companies in the MedTech…
Revolution or Hype? The MedTech industry faces the challenge of balancing regulatory requirements, efficient production processes, and innovative digital transformation. SAP serves as the backbone of IT infrastructure for many…
Latest Updates from Australia’s TGA The Australian Therapeutic Goods Administration (TGA) has made significant progress in implementing the Unique Device Identification (UDI) system for medical devices. We are pleased to…
FDA Updates GUDID Guidelines: Transition to GMDN Codes Updated FDA Guidelines for the Global Unique Device Identification Database (GUDID) The U.S. Food and Drug Administration (FDA) has released a new…