From everyone at Quality Systems Now, we wish you a Merry Christmas and a positive start to the New Year. Thank you for your continued engagement, professionalism, and commitment to quality and compliance.
The regulator’s mid-2025 review acknowledges that the existing, technology-agnostic, risk-based framework remains fundamentally appropriate for SaMD and AI-enabled medical devices
AusBiotech 2025 offered a valuable reflection point for the biotechnology sector, particularly regarding GMP and regulatory compliance.
The proposed temporary GMP exemption by the TGA for personalised bacteriophage therapy manufacture in Australia marks a significant regulatory development for the emerging phage‑therapy sector.