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Steve McCarthy
The ideal of proactive quality has been the holy grail of chief quality officers in the life sciences industry for at least five years, but few, if any, have realized the vision. Industry has since...
    IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory...
    Researchers at the National Institute of Standards and Technology (NIST) have produced synthetic gene fragments from SARS-CoV-2, the virus that causes Covid-19. This material, which is noninfectious and safe to handle, can help manufacturers produce more accurate and reliable diagnostic tests for...
    As Covid-19 rages on, warning sirens have sounded of late amid a flurry of headlines surrounding ultraviolet C (UVC) light device-safety issues. Rightfully so, as the current pandemic has ushered in a veritable wild west of UVC gadget deployments with subpar consumer safeguards, instructions, or...
    The Covid-19 pandemic has crippled the airline industry. Passenger numbers are down more than two-thirds from last year, and airlines have been canceling flights and shutting down routes. It’s frustrating for travelers, but for patients on organ transplant waiting lists, the loss of flights can...

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