adminMTE_04792022-10-06T10:52:22+00:00November 4th, 2021|Categories: Various|Tags: 510K, BLA, denovo, Device Software, FDA, HDE, IDE, Medical Devices, PMA, SaMD, SiMD|
Content of Premarket Submission for Device Software Functions FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. This document is intended to cover: ▪️ [...]
adminMTE_04792021-01-19T14:53:27+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: AI, Artificial Intelligence, Digital Health, FDA, Machine Learning, Regulatory, SaMD, Software|
The FDA has released an action plan to develop a regulatory framework on artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). The FDA aims to publish the draft guidance this year. As a Digital Research Organization, Meditrial understands [...]
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