Overview  Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications. Challenges include managing risks, demonstrating clinical evidence, and ensuring data security. Harmonisation efforts and evolving frameworks...

Overview  The future of (SaMD) Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring. Emerging trends emphasise real-time data integration, stronger regulatory measures, and...

Overview  Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device. Software as a Medical Device...

Overview  Quality Management Systems for SaMD requires compliance with regulatory standards, implementation of robust quality management systems, and risk management through design controls, testing, and post-market surveillance. It also involves maintaining thorough...

Overview  Clinical validation of Software as a Medical Device (SaMD) ensures a software's safety and effectiveness for its intended medical use. It involves rigorous testing and evidence collection to demonstrate that the...