FDA Cautions Medical Device Shortage Could Affect Children
The FDA warned of a shortage of pediatric medical devices and urged Congress to bolster its ability to track and anticipate these issues.
Tag: medical device standards
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AAMI Updates Ethylene Oxide Sterilization Standard
AAMI has updated its ethylene oxide (EO) sterilization standard, ANSI/AAMI ST24:2024, addressing new technologies and industry challenges.
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AAMI Revises Standards for PPE Use in Healthcare
AAMI has released a revised American National Standard containing new and crucial information for the manufacturers and users of personal protective equipment (PPE) in the healthcare space.
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FDA Cautions Medical Device Shortage Could Affect Children
The FDA warned of a shortage of pediatric medical devices and urged Congress to bolster its ability to track and anticipate these issues.
ASME’s New Medical Device Standard Aims to Spur Patient Innovations
The American Society of Mechanical Engineers’ new V&V 40 standard assesses the credibility of computational modeling through verification and validation with application to medical devices, including endovascular and orthopedic devices, heart valves, and stents.
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