Human Factors Testing Capabilities

We understand that our clients come to us at various stages of the medical device and Software as a Medical Device (SaMD) design and development process looking for varying levels of guidance. That’s why we develop a unique human factors testing (HF), User Experience (UX) and User Interface (UI) package for each of our clients, customizing our services to meet their specific needs.

Improvita UX-UI Design for medical software

UI / UX Design Research & Testing

We will help you make sure the right decisions are being made early on in your product development process. We do this through usability testing and analysis.

  • UX Testing to evaluate a user’s emotions and attitudes about using any device.
  • UI Testing to evaluate the visual / graphic presentation of a digital device and its intended user.
  • Usability testing to test the ease of use and satisfaction of the user. Using a SUS (system usability scale), we will score your device so you know if it will pass Ease of Use requirements.
SaMD testing with doctor

Research

We use a variety of research tools and methodologies to uncover unmet needs and to identify user interface issues and opportunities.

  • In-depth interviews
  • Gap analysis to regulatory standards
  • Ethnographic research: The study of people through observation and point of view of the subject.
  • Contextual inquiry
  • User needs identification
  • Focus groups: in person, digital
Human Factors engineering (hfe) and testing on a medical device

Usability & Human Factors Testing

To assure the optimization of your device while also meeting FDA testing guidelines, we use a variety of testing processes and methods.

  • Human factors formative (verification) is early stage testing to identify problems.
  • We will set up criteria through risk management activities to identify areas where participants would fail, pass or have a “slip-up” or “close call” while using your product.
  • Instructions for use (IFU) design
  • Human factors summative (validation) is validation testing as mandated by the FDA
  • SaMD / Clinical validation testing (plan and execute)
    • Model training & validation: pattern recognition, neural networks, algorithm, machine learning, artificial intelligence (AI), data mining, problem solving
    • AI and Machine Learning analytical testing (plan and execute)
Improvita customizable medical device testing facility

Customizable Medical Device Testing Lab

We can create the environment in which your product needs to be tested—whether your product is for home, lab, or hospital use. Our medical device testing lab is flexible and customizable to your needs.

  • 5 testing rooms
  • 2 conference rooms that can accommodate live video feed
  • Good Laboratory Practices (GLP): all our testing rooms and conference rooms follow GLP
  • Video monitoring and on-site streaming capabilities

Recruiting

Our rapidly growing, multi-disciplinary database helps us identify and screen people who can provide you with valuable insight about your product. Our in-house team can recruit from highly specialized users to lay users based on your product needs.

Join Our Research

If you are a physician, nurse practitioner, RN, LPN, physician assistant, reprocessing technician, or other medical professional, we need your help.

HEALTH CARE PROFESSIONALS NEEDED

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Let’s empower health, together.

Improve Life.

Contact Improvita

6410 Enterprise Lane
Ste. 100
Madison, WI 53719
608-203-9748

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