For therapeutic goods, biotechnology, and medical device startups, securing funding is not simply a matter of demonstrating innovative science. Investors require evidence of robust governance, clear regulatory pathways, and effective risk management.
May 2026 be a year of innovation, regulatory excellence, and continued progress in improving patient outcomes worldwide.
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