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  • Feature ArticlesFeature Articles

    What is a Wearable Device? Lifestyle Device vs. Medical Device

    This article discusses how to determine when wearable lifestyle devices, referred to as fitness trackers, might be categorized as medical devices. In cases where fitness trackers are used in particular ways, their categorization as a medical device carries with it specific requirements for compliance to regulations. The article provides useful information to regulatory personnel in assessing how much compliance to the Health Insurance Privacy and Portability Act (HIPPA) ...
  • Feature ArticlesFeature Articles

    Ethics and Risk Management: Lessons from the VW Defeat Device

    This article discusses risk management practices from the automotive industry and what the biomedical industry can learn from recent current events. Biomedical professionals are constantly reminded of ethics and risk management in all roles in the field. The financial impact of an organization failure can be nearly limitless when regulatory and/or legal risks are not mitigated through the quality system. As a profession, it is clearly understood biomedical innovations ...
  • Feature ArticlesFeature Articles

    The Four Cs of Regulatory Professional's Use of Webinars

    This article discusses the potential applications of webinars as an appropriate tool for use by regulatory professionals in the workplace. "Webinars," seminars conducted over the Internet, have become useful and prominent in the workplace. In some fields, webinars might be considered routine modes of communication and instruction. The power of webinars resides not in the technology used to conduct them, but in the many benefits they can bring to regulatory organization...