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Navigating the Landscape for Over-the-Counter or Direct-to-Consumer IVD Tests

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Healthcare diagnostics has seen a significant increase in over-the-counter (OTC) or direct-to-consumer (DTC) testing. A trajectory that was already in the making prior to COVID-19, this area has increased at a faster pace as more consumers are comfortable performing OTC tests at home. This change in consumer expectation, as well as an evolution of global regulatory requirements, has led to increased considerations and requirements by IVD manufacturers to produce robust testing options.

Join NAMSA for this webinar as we evaluate those enhanced requirements specifically as they affect human factors and usability engineering to insure all IVDs are safe and effective for the intended users, uses and use environments. Early understanding of these requirements is crucial and can influence the device display, controls, functions, results interpretations, instructions and countless other design inputs impacting the consumer.

Participants of this webinar can expect to learn how to:

  • Define human factors and usability and how that definition may change based on country
  • Identify when in the product development lifecycle human factors and usability requirements should be considered
  • Apply ISO 14971 and IEC 62366 standards as part of a formal risk analysis in the development of a human factors/usability risk assessment
  • Translate risk assessment to a human factors and usability testing plan and where key activities can be leveraged for multiple markets


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