Unclear labelling can lead to device misuse, regulatory non-compliance, and potential harm. And for many manufacturers, simulating real-world use environments or recruiting volunteers to test usability is simply not an option. Without access to specialised expertise and facilities, ensuring labelling that is truly intuitive and compliant becomes a significant challenge. At Eurofins MDS network of laboratories, we understand the science and the regulations, providing labelling that safeguards patients, supports professionals, and ensures compliance. Our Human Factors experts work closely with you to evaluate every component of your label, from device packaging and instructions for use (IFUs), to warning labels and graphics. We draw on insights of usability testing, user interface design, and regulatory guidance to ensure your labelling is not just compliant, but effective. 

We apply human factors principles to identify labelling risks early, and reduce user error through:

• Accessible design for readability and comprehension
• Clear, consistent phrasing and terminology
• Colour coding of essential information
• Emphasis on critical steps and warnings
• Logical layout and user-friendly formatting
• Visual aids to address/reduce cognitive load

Where required, we also conduct label comprehension studies for regulatory submissions, ensuring users fully understand the device, its risks, and safe use. These studies are especially valuable for non-prescription devices or devices where the FDA requires proof that users will act appropriately on label instructions.