8. Guidance document: Off-The-Shelf Software Use in Medical Devices FDA itself has said that section 3.2.2 of this guidance is out-of-date because it characterizes laboratory information management ...
DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes ...
Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the Food and Drug Administration (FDA) took a more active approach to medical ...
The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
Hospitals that are considered device manufacturers under the new medical device data system regulation may be subject to FDA inspections, according to an Association for the Advancement of Medical ...
Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window Dhruva, Kesselheim, and Redberg are all professors of medicine.
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