AAMI Backs Expanded Use of Consensus Standards Under MDUFA VI
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
The subsidiary will partner with startups and industry to accelerate new imaging technologies, including AI.
The organization warns that trade restrictions on medical devices could disrupt patient care and exacerbate existing supply chain challenges.
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
ASHE announced the winners of its 2024 Energy to Care Awards, recognizing healthcare facilities that have reduced energy use and emissions.
Read MoreThe Colorado Association of Biomedical Equipment Technicians (CABMET) has introduced free CBET flashcards and crossword puzzles, available at CABMET’s study resource page. Here, CABMET President Leticia Reynolds shares the inspiration behind these new study tools.
Read MoreAdvaMed and ABHI renewed their MOU to enhance collaboration on AI regulation, trade policy, and regulatory convergence, aiming to improve patient access to advanced medical technologies in the U.S. and U.K. medtech markets.
Read MoreACHC launched two new specialty credentials, the Distinction in Age-Friendly Care and the Distinction in Outcomes, to recognize quality care.
Read MoreAAMI TIR48 provides guidance for manufacturers of combination products to comply with FDA CGMP regulations.
Read MoreRalph Basile, a standards corporate executive at Healthmark, has been appointed to a key philanthropic position with the AAMI Foundation.
Read MoreECRI made recommendations to the FDA for improving the accuracy of pulse oximeters on patients with darker skin tones.