Australia’s Unique Device Identification (UDI) Mandate: Immediate Action The Australian Therapeutic Goods Administration (TGA) has introduced a mandatory Unique Device Identification (UDI) regulatory framework, which came into
The New Dual Regulatory Framework for Medical AI The European Union’s regulatory environment for medical devices utilising Artificial Intelligence (MDAI) is now defined by a complex dual
Highlights from the August-September 2025 Client Feedback Survey At Advena Ltd, our partnership with you is built on trust, efficiency, and expert regulatory support. We understand that
By James Bradbury, Operations and Compliance Director
