Clear, precise and compliant user information is critical to safe and effective product use. We design, develop and test Patient Information Leaflets (PILs), Instructions for Use (IFUs), labels and related documentation to ensure they are readable, accurate and aligned with regulatory expectations.

Our service covers document strategy, content structuring, artwork and formatting, followed by structured Readability Studies to generate objective evidence of user comprehension. All work is delivered in line with applicable regulatory requirements, including EU MDR, UK MHRA and FDA expectations.

The result is documentation that is not only compliant, but genuinely usable by patients, caregivers and healthcare professionals.

Packaging plays a critical role in safe product access and correct use. We design and develop packaging systems that ensure patients and users can access the medical product easily, intuitively and safely.

Our service includes structural and graphical design, artwork development, material selection and usability-focused optimisation. We then generate supporting evidence through structured User Studies to demonstrate safe access, correct handling and alignment with human factors requirements.

This ensures packaging is not only functional and compliant, but robustly supported by user data where required for regulatory submission.