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International Standards Conference 2022 | AAMI

    https://www.aami.org/standards/isc-2022
    For more than three decades, AAMI has hosted the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation; the premier event for …

Good to Be Back! 2022 International Conference on Medical …

    https://array.aami.org/content/news/good-back-2022-international-conference-medical-device-standards-and-regulation-person
    The AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation is being hosted at AAMI headquarters on October 18-19, 2022 (with …

AAMI Main Page | AAMI

    https://www.aami.org/
    The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 …

AAMI Events | AAMI

    https://www.aami.org/events/
    AAMI Events | AAMI. Design Control Requirements - Integrating the Quality System Regulation (Feb23) February 15 to 17, 2023. Register. Introduction to Combination …

Human Factors for Medical Devices | AAMI

    https://www.aami.org/training/training-suites/human-factors/human-factors-for-medical-devices
    Medical device manufacturers with robust human factors processes are leading the market, delivering better clinical outcomes and better quality. Attend AAMI’s three-day …

Medical Devices and Technology | AAMI

    https://www.aami.org/medical-device-manufacturer
    The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has issued an initial framework for communicating medical device …

Wireless Medical Devices | FDA

    https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices
    The Association for the Advancement of Medical Instrumentation (AAMI) TIR 69 - Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and …

Sterilization for Medical Devices | FDA

    https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
    The FDA is working actively with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize …

Leveraging Medical Device Architectures for Better Alignment of …

    https://array.aami.org/content/news/leveraging-medical-device-architectures-better-alignment-risk-mitigation-approaches
    The risk a device poses to the patient and/or user is a major factor in determining the class to which it is assigned by the Food and Drug Administration (FDA). …



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