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    The Only Human Factors Planning Guide You Need

    Documenting a human factors engineering plan is critical. Download our guide to jumpstart yours with our proprietary human factors plan table of contents so you don’t miss any of the essential components.

    Your Guide to FDA Device Classification

    Follow this one-page infographic guide to lead you to the proper FDA class for your medical device. If you don’t know which class your product falls into, you risk creating a development plan that doesn’t align with FDA requirements and doesn’t properly mitigate risk.

    Medical Device Developers: Give IFUs and Information Design Details Their Proper Due

    To shape a positive medical device user experience, you should focus on product information design throughout your medical device development process. For instance, developers too frequently procrastinate their Information for Use (IFU) documentation.In doing so, you’ll set your product on a smoother path to FDA approval and subsequent market success.

    How to Complete the User Needs Section of User Interface Requirements

    To meet the FDA’s standards for medical devices, you must complete user interface specifications or requirements. So how do you properly complete the user needs section of user interface specifications? Our template offers guidance on doing just that, including a blank chart to get started on your own user needs documentation.

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