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Emergo by UL explains the European Artificial Intelligence Act (AIA) and its impact on medical device and IVD regulation. Learn about the scope, classification, conformity assessment and operator obligations under the AIA.
14 de may. de 2024 · Maintaining safer medical devices: how medical device regulations, standards and guidance are keeping pace with the proliferation of medical device software.
Hace 2 días · By Milena Borrasca, Luiz Levy, Priscila Sanada and Evangeline Loh Brazilian medical device regulator ANVISA has published new legislation allowing manufacturers of higher-risk devices to leverage registrations from some foreign regulatory authorities when applying for market access in Brazil.
15 de may. de 2024 · Visit Emergo by UL at booth no. 4 at the third annual European Medical Device Human Factors Conference 2024.
24 de may. de 2024 · Emergo by UL human factors specialists share ways manufacturers can “take credit” for informal HF work by transforming it into submission-worthy content.
24 de may. de 2024 · Overview of the Common Specifications Policy. The purpose of the CS policy is to improve the safety profile of high-risk IVDs requiring manufacturers to comply with additional measures to protect patients and public health before placing these IVDs on the market.
Hace 3 días · Emergo Entertainment, founded in 2019, is a game studio that believes in the power of creativity and emergent systems in gaming. Their partnership with Nordcurrent Labs, an experienced publisher with a global presence, ensures that Fireside will be a polished, multiplatform game that reaches a wide audience.
