Artificial Intelligence and Machine Learning in Software as a Medical Device
USFDA – Review framework for artificial intelligence-based medical devices
More from Software as Medical Device - SaMDMore posts in Software as Medical Device - SaMD »
- Australia – TGA – Actual and potential harm caused by medical software
- EU – MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- Australia – New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
- TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
- EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
More from United States Food and Drug Administration - US FDAMore posts in United States Food and Drug Administration - US FDA »
- EU – Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- US – Ventilator Supply Mitigation Strategies – Letter to Health Care Providers
- US – Update on the Ethylene Oxide Sterilization Master File Pilot Program
- US – FDA Engagement to Mitigate Potential Shortage of Personal Protective Equipment (PPE)
Be First to Comment