Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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  • The image shows a professional workspace divided by a glass window. In the foreground, a person is seated at a desk with multiple computer monitors and a laptop, seemingly observing or recording data. Through the glass window, two individuals are visible in a clinical or lab-like setting. One is seated in a chair, wearing a mask and scarf, while the other, dressed in scrubs and gloves, appears to be conducting a procedure or simulation. The environment suggests a usability testing scenario.

    There are a lot of things to consider when creating a summative usability test. The first time can be overwhelming. What scenarios do I test? How do I identify a critical task? How many participants do I need? Do I need to test the training? In this eGuide I will help you avoid common mistakes, like using a formative test structure for a summative usability test. I will also provide some tricks and tips to help you get the most out of your test participants and testing.

  • IEC-62366-1:2015 human factors engineering

    Exploration of applying IEC-62366-1:2015 or human factors engineering to the design of medical devices compared to the FDA guidance document.