Confusion and mistrust can cloud a lot of the conversations about the COVID-19 vaccines. From safety to sample size, many people have expressed concerns about how quickly the vaccines were developed, especially in comparison to more traditional vaccines, and whether corners were cut in the process. Read more
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In today’s fast-paced business world, cloud-based services are taking over. These services are identified with terms like “platform as a service” (PaaS), “software as a service” (SaaS), and even “infrastructure as a service” (IaaS). Each of these refers to a service based in data centers that you access through the internet—as opposed to local servers in your work environment. It is only natural. Read more
What is Root Cause Analysis? What is its unique role in formative vs. summative testing? How should it be planned for before usability testing even starts? Read more
Check out Design Science founder Steve Wilcox's thoughts on ethnography, prototyping, the FDA, and more through TechnologyAdvice’s TA Expert Interview Series. Read more
Designing usability studies that are "representative" is not only necessary for valid data, it's also an FDA requirement. Chad Uy shares some methods for maintaining realism to ensure representative usability studies in his recent article for Med Device Online. Read more
Understanding the ramifications of less-than-perfect validation testing results can be complex. In his recent article for Med Device Online, Peter Sneeringer presents 6 questions to help companies decide if errors seen during testing indicate a likelihood that the FDA will reject their submission. Read more
On April 15th, the Food and Drug Administration will begin accepting applicants through its new Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“Expedited Access PMA” or “EAP”). Read more