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    Author Archive for: "Elyse Hallett"
    Home » Archives for Elyse Hallett
     Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps
    By Elyse Hallett
    In Human Factors & Usability Testing, Medical Product Design
    Posted February 20, 2023

    Your Medical Device Is Not Ready for a Human Factors Validation Study Until You Complete These 4 Steps

    If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and [...]

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     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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     Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering
    By Elyse Hallett
    In Human Factors & Usability Testing, Medical Product Design
    Posted July 29, 2022

    Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering

    Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for [...]

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     Why User Needs Matter During Medical Device Development
    By Elyse Hallett
    In User Insights & Design Research
    Posted April 18, 2022

    Why User Needs Matter During Medical Device Development

    To market any type of product successfully, it’s important to identify how people will use it and what difference it will make in their lives. Put simply: You must understand your end users’ [...]

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    INSIGHTS
    • These Are the Contents of a Proper Product Requirements Document
      These Are the Contents of a Proper Product Requirements Document
      August 8, 2023
    • Medical Device Development and Professional External Resourcing: How to Manage Product Development in Times of Economic Uncertainty
      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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