FDA Recognizes Updated AAMI Sterilization Guidance
The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.
Tag: medical device standards
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AAMI President Pamela Arora on Advancing HTM Standards
In this podcast, AAMI President Pamela Arora discusses the organization’s commitment to advancing HTM through standards, promoting diversity, and maintaining neutrality.
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AAMI Publishes Water Quality Standard for Medical Devices
AAMI has published a new standard that establishes requirements for the quality of water used to process medical devices.
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FDA Recognizes Updated AAMI Sterilization Guidance
The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.
FDA Finalizes Overhauled Guidance on Device Conformity Testing Pilot
The FDA has issued updated, finalized guidance on a pilot program for laboratories to carry out premarket testing of medical devices.
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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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