Summary As per MDR, 2017, “clinical investigation” means the systematic study of an investigational medical device in or on human. participants to assess its safety, performance or effectiveness Clinical investigation approvals are...

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...