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Global value chains highlight the importance of standards.
Elizabeth Gasiorowski Denis
Change is nothing new. Nobel laureate Bob Dylan sang that “the times they are a-changin’” back in 1964. The difference today is the pace of change. In his book, Thank You for Being Late: An...
    Digital Medical Devices
    It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By...
    Every company is in business to take risks. Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to identify opportunities and take them when beneficial, but the amount of risk must be understood. Whether it...
    With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business: computer...
    In our July 7, 2017, episode of QDL we look at apprenticeships, the Antikythera mechanism, and risk-based thinking in operations. “Demand-Driven Education to Close Skills Gap” Speaking at the National Association of Manufacturers Summit in Washington, D.C., Secretary of Labor Alexander Acosta and...

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