Readability Studies are conducted to confirm that user information is understood by the intended audience. Regulatory bodies require evidence that patients, caregivers and healthcare professionals can locate, comprehend and correctly apply key information.

We perform structured, individual comprehension testing using representative users. Testing focuses on critical safety information, correct interpretation of instructions and the ability to act appropriately based on the content provided.

All studies are designed in line with EU EMA, MHRA and other applicable regulatory expectations. Deliverables include a complete, submission-ready report demonstrating that the information is clear, usable and supported by objective user data.

Effective documentation is essential to safe and compliant product use. We design and develop Patient Information Leaflets (PILs), Instructions for Use (IFUs), labels and related materials to ensure clarity, precision and regulatory alignment.

Our service includes content structuring, plain-language optimisation, artwork and formatting, followed by evidence generation through Readability Studies where required. Documentation is developed in accordance with applicable standards and regulatory frameworks, including EU MDR and FDA expectations.

The result is user information that is not only compliant, but practical, understandable and defensible during regulatory review.