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The following documents, developed by the AAMI COVID-19 Response Team, are available for free download at www aami org/COVID_CRs: AAMI CR501:2020, Emergency Use Ventilator (EUV) Design Guidance AAMI CR502:2020, End User Disclosures for Emergency Use Ventilators (EUVs) AAMI CR503:2020, Emergency Use Resuscitator Systems Design Guidance AAMI CR504:2020, End User Disclosures for Emergency Use Resuscitator Systems AAMI CR505:2020, Emergency Use CPAP/BiPAP Design Guidance AAMI CR506:2020, End User Disclosures for CPAP/BiPAP Possible Implications for the MDR Delay With the regulatory requirements of the European Union\'s Medical Device Regulation (MDR) due to take effect May 26, the European Commission (EC) proposed—and the European Parliament overwhelmingly approved—a one-year delay to MDR to allow member states to dedicate more time and resources to fighting the COVID-19 pandemic Kevin Fu, associate professor of electrical engineering and computer science at the University of Michigan and a member of AAMI\'s device security working group (SM-WG05), is leading this interdisciplinary 60-member group that consists of scientists, engineers, clinicians, and students Larry Hertzler, who has worked in the clinical engineering field for 40 years, holding positions in hospitals, hospital systems, equipment insurance, and the largest service organizations in the U S Clark Houghtling, vice president of business development and technical affairs for Cosmed in Hickory, NC Artificial Intelligence Whitepaper Sets an Agenda AAMI and BSI, the United Kingdom (UK) national standards body and international standards developing organization, have teamed up to respond to questions about artificial intelligence (AI) and medical devices in a new position paper, Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance, which was published in April
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