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 investigations are crucial...

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...