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    Tag Archives for: "summative usability testing"
    Home » summative usability testing
     3 Steps to an FDA-Worthy Human Factors Validation Study
    By Elyse Hallett
    In Human Factors & Usability Testing, Medical Product Design
    Posted November 1, 2022

    3 Steps to an FDA-Worthy Human Factors Validation Study

    Human factors validation testing shows you’ve done your due diligence to mitigate identified hazards and the resulting harms your device might cause users and patients. For the majority of [...]

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     Balancing Market & Technology Product Needs by User Testing Early and Often
    By Andy Moulds
    In Human Factors & Usability Testing, Medical Product Design
    Posted August 21, 2018

    Balancing Market & Technology Product Needs by User Testing Early and Often

    After months of allocating resources to your new product development project, it has moved into the validation process and user testing. There is the knock on your door and your team approaches [...]

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      These Are the Contents of a Proper Product Requirements Document
      August 8, 2023
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      Medical Device Development and Professional External Resourcing: How to Manage Product Development in Times of Economic Uncertainty
      July 18, 2023
    • Your Medical Device’s User Interface Specification Is More Powerful Than You Think
      Your Medical Device’s User Interface Specification Is More Powerful Than You Think
      July 10, 2023
    • Risk Management Simplified: Streamline Your FDA Submission with a Hazard Analysis Worksheet
      Risk Management Simplified: Streamline Your FDA Submission with a Hazard Analysis Worksheet
      June 26, 2023
    • Does Your Medical Device Need Design Controls? Here’s What You Need to Know.
      Does Your Medical Device Need Design Controls? Here’s What You Need to Know.
      June 20, 2023
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