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  • Benchmarking Quality Assurance

    By Mark Davis on October 11, 2018 | Leave a response
    Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards.  The study includes aggregate and anonymized data from 31 large medical companies, including Fisher & Paykel Healthcare, ResMed, Smith & Nephew, and Medtronic, among others.  ...

  • FDA Launches ‘Quik’ 510(k) Review Pilot Program

    By Nathan Lee on | Leave a response
    The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) ("Quik") Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third.  The pilot, dubbed as "a Turbo Tax for information submitted in 510(k)s," by FDA Commissioner Scott Gottlieb, will allow device manufacturers to submit premarket notifications electronically using ...

  • Apple’s Latest Watch Receives FDA Approval For ECG Functionality

    By Aaron Johnson on | Leave a response
    Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of Apple’s Watch—Series 4—features a larger display screen, thinner case, a new interface, and, according to Apple “revolutionary health capabilities.” These health capabilities include electrocardiogram (ECG) functionality, which has ...
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