Formative & Summative Testing

Evaluating Usability, Reducing Risk, and Supporting FDA Submission

Formative and summative testing are critical steps of Human Factors Engineering (HFE). We set up the proper testing to ensure your device is supported by robust data for regulatory submission.

Why It Matters

Medical devices are required to  undergo usability evaluations that prove they can be used safely and effectively. Formative testing identifies usability risks early and  summative testing confirms that those risks have been addressed before the final design.

Our Approach

We design and execute structured usability evaluations that replicate real-world clinical use scenarios and comply with all FDA requirements. Our services include every step of the highly logistical process from participant recruitment and study design to logistics, facility coordination, and facilitation. 

H2: Formative Testing Includes:

• Early-Stage Usability Testing

• Rapid Iterative Feedback Cycles

• Concept Evaluation and Risk Identification

• Design Refinement Recommendations

Summative Testing Includes:

• Final-Stage Validation of User Interface

• FDA-Compliant Study Protocol Development

• Simulated Use Testing with Representative Users

• Data Collection, Analysis, and Interpretation

• Compilation of Summative Evaluation Reports

What You Get

Clear, well-documented usability data, tracking and feedback that supports your Human Factor decisions and demonstrates that your product can be used safely and effectively.