Tag Archives: Compliance

Cancer test maker Grail made its debut on the Nasdaq on Tuesday, marking a significant pivot nearly four years after its initial public offering plans were disrupted by a takeover from Illumina. This development follows a prolonged period of regulatory disputes involving both the U.S. Federal Trade Commission and the European Commission, which challenged the […]

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Despite the prevalence of modern document management options, many startup medical device companies surprisingly still rely on traditional methods such as paper records and “digital paper” tools like spreadsheets, Dropbox, and other general-purpose software. These methods pose significant risks to both business operations and product quality within a Quality Management System (QMS). There are inherent […]

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Insulet, a prominent player in the diabetes care sector, is actively seeking to broaden the use of its Omnipod 5 insulin pump to include individuals with Type 2 diabetes after its recent regulatory submission to the U.S. Food and Drug Administration (FDA). The move could significantly impact the treatment landscape for the 30 million Americans […]

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