MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
Posts tagged as “SaMD”
New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Clinical Decision Support Software
Final and update guidances – Software … the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the…
There’s a bit of discussion in Elsmar about EU MDR Classification Rule 11. – Please explain MDR Rule 11 to me. Please feel free to…
Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD)
TGA presentation: How the TGA regulates software, 7 March 2019
Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices Artificial Intelligence and Machine Learning…