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Software as a Medical Device (SAMD): Qualifications & Regulatory Requirements

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Over the last 20 years, the amount of software used in and around medical devices has increased. The medical device industry has observed an acceleration in this trend thanks to the emergence of the “internet of things” (IoT) and the availability of a multitude of commercial off the shelf platforms. Items such as personal computers, smartphones, virtual networks, wireless connectivity, cheaper and better sensors, cloud computing, big data and Artificial Intelligence (AI) and Machine Learning (ML) are transforming how work gets accomplished across every industry.

Software is progressively becoming a crucial component in medical devices and even more pervasive in healthcare. The good news is that U.S. Food and Drug Administration (FDA) is getting serious about digital health. The agency’s existing regulations address public health risks of software when embedded in a traditional medical device. They have also recognized that their “traditional approach to moderate and higher risk hardware-based medical devices is not well suited for the faster iterative design, development and type of validation used for “software device functions.”

Join NAMSA for this webinar to learn more about SaMD and leave with a better understanding of how to:

  • Define Software as a Medical Device (SaMD)
  • Determine if a device qualifies as SaMD
  • Recognize the challenges and opportunities of SaMD

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