The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation ...
MedPage Today on MSNOpinion
Easing AI and Wearables Regulation Is a Risky Move
The FDA's planned rollback of oversight shifts risk onto patients and clinicians ...
The CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium has published new consensus recommendations today in The Lancet Regional Health Europe, that set out ...
New Approach to Clinical Trial Design Helps Medical Devices Better Meet Patient Needs and Priorities
ARLINGTON, Va.--(BUSINESS WIRE)--A Medical Device Innovation Consortium (MDIC) program today released a new framework that provides U.S. medical device companies a systematic approach for ...
Medical devices with artificial intelligence (AI), machine learning (ML), and similar “intelligent” systems come with additional layers of quality and regulatory scrutiny. In addition to proof of ...
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 ...
You're deep in clinical research operations, and decentralized clinical trials software has become the go-to for handling remote and hybrid models effectively. These clinical trials software fuses ...
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