An Introduction to HIPAA Compliant Software
In today’s fast-paced business world, cloud-based services are taking over. Read more
Tag Archive for: FDA
MD+DI Article: “Root Cause Analysis: Adventures in Medical Device Usability”
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
Listen: Podcast on Human Factors & Usability Testing for TechnologyAdvice
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
MDO Article: “Achieving Realism In Human Factors Work: How To Stay Out Of Fantasy Land”
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.
MDO Article: “How To Know You’ve Passed Validation Testing (And What To Do If You Haven’t)”
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.
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FDA to Accept Applications for Expedited Medical Device Approval
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