The path to regulatory approval is never simple, especially when patient safety depends on how well a drug delivery device performs in the hands of real users. When dealing with regulatory submissions or a device redesign, proving that your device or product works isn’t just good science, it’s a regulatory expectation. But conducting comparative use testing without sufficient internal resources or regulatory clarity can be often overwhelming. 

Eurofins Medical Device Services network of laboratories brings the precision, expertise, and infrastructure needed to deliver robust, regulatory-ready comparative use studies. Whether you’re uncertain of when to start testing, sample size requirements, lack a controlled environment, or need to know more about how to define test variables or participant groups, we support you every step of the way. 

Our comparative use testing service is designed to evaluate how users perform critical tasks across different versions of a product. We assess if the human factors associated with a generic product match those of the reference listed one – even when key design differences exist. These studies are essential when differences are identified in threshold analyses and are often required by regulatory authorities. 

With extensive experience in human factors and usability testing, our team manages all aspects of study design and execution: 

• Defining and recruiting appropriate participants
• Preparing informed consent and training materials
• Selecting and simulating realistic test environments
• Identifying and evaluating critical tasks
• Capturing usability metrics and conducting in-depth analysis 

Our experts provide detailed insight into whether differences in design could lead to higher error rates, impacting safety or effectiveness. Our findings also help demonstrate that the device’s user interface does not compromise its intended use, even under real-world conditions. 

Through our validated processes, state-of-the-art simulation environments, and expert study teams, the Eurofins Medical Device Services network of laboratories will help you generate the evidence required to support comparability claims with confidence.