Discover how the HEALTH AI Act uses generative AI to reduce administrative burden. Read our complete guide to H.R. 5045 and ...
Medical firms develop PFAS-free materials matching PTFE performance while addressing environmental and regulatory concerns.
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
A significant market opportunity lies in providing comprehensive training on technical documentation for medical device manufacturing, focusing on DHF, DMR, and DHR. This ensures regulatory compliance ...
AI is reshaping the life sciences industry in ways that are no longer hypothetical. The question is no longer whether to ...
Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed interpretations of MDR and IVDR PMS ...
Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...
December 2025 marked an exceptionally active period for life sciences regulation in the European Union (EU). Within the space of a few days, EU institutions have reached political agreement on the ...
To wrap up an already complicated 2025 for medtech, FDA has lost two major leaders in the digital and medical device space. According to sources, Jessica Paulsen, acting deputy director of FDA’s ...
Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...
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