IFU Design & Testing
For many medical devices and IVDs, instructions for use (IFU) are a key component of the approval process – and, at the same time, an important tool for ensuring safe use. Well-designed IFUs help users understand products correctly, perform critical steps reliably, and avoid potentially dangerous use errors.
We help you design your IFUs to meet the requirements of your target markets and test them with users. From product analysis through IFU design and testing to final validation, we design your IFUs to not only meet regulatory requirements but also guide your users safely through the application process.
How we help
We help you turn complex product information into an IFU that is easy to understand, visually clear, and safe to use – from the initial consultation through final validation.
- Consulting on information structure and presentation based on your product and your target markets
- IFU Design Based on Corporate Identity or a New Visual Style
- IFU testing with real users to assess comprehensibility and risk controls (including recruitment, implementation, evaluation, and revision)
- Delivery of the IFU (including multilingual versions) and relevant design assets (e.g., as a digital guide or print file)
How does IFU Design & Testing work at our company?
01. Consulting – Clarifying the Product, Users, and Requirements
We determine what information your IFU needs to convey, who will use it, and which requirements are relevant to your target markets. This provides a clear foundation for the structure, content, and design.
02. IFU Design – Presenting Information in an Easy-to-Understand Way
We translate product information and usage instructions into clear, visually understandable IFUs – whether in print or digital format. In doing so, we take your corporate identity into account or, if necessary, develop a suitable visual style.
03. IFU Testing – Testing with Real Users
We test the IFU with appropriate participants in the lab, in the field, or remotely. This ensures that the target audience understands the instructions, applies them correctly, and is guided safely through the process.
04. Optimization – Incorporating Insights in a Targeted Manner
We analyze comprehension issues, ambiguities, and potential use errors. Based on this analysis, we make targeted adjustments to the structure, content, or design.
05. Delivery – Received the finalized IFU
You will receive the final IFU as well as relevant design assets (e.g., a print file or a digital assistant). This will provide you with a clear, user-friendly, and regulatory-compliant IFU for your target markets.
Certified for Excellence & Awarded for Design
We are certified to ISO 13485 and ISO 27001. This allows us to combine verified quality processes with secure handling of sensitive data – specifically for projects in the medical device and IVD sectors.
Our commitment to quality is also reflected in the design awards we have won. Among other accolades, we have won the “Red Dot Winner User Interface Design” award multiple times, as well as the German Design Award.
Our References for IFU Design & Testing
Why Custom Medical?
Experience with Medical Devices and IVDs: Our team has many years of experience in the design of medical devices and IVDs, as well as their IFUs. That is why we know how instructions for use must be structured to guide users safely and clearly through the application process.
Focus on User Understanding: An IFU only works if users understand it in the context of its application. That is why we ensure a clear structure, understandable language, and appropriate visual guidance for each target audience.
Regulatory Compliance Built In: We take the requirements of your target markets into account from the very beginning. This results in an IFU that is easy to understand, supports safe use, and can be seamlessly integrated into your technical documentation.
Design & Testing from a Single Source: We combine information architecture, visual design, and testing with real users. This helps identify ambiguities, misunderstandings, and potential user errors early on.
Realistic testing conditions: Our UX and medical usability labs enable us to conduct IFU testing under realistic conditions. We can also conduct structured field studies or remote tests on your behalf.
Final deliverables for your continued work: You will receive a finalized IFU – in multiple languages upon request – as well as relevant design assets. This will allow you to reuse your instructions consistently and efficiently implement future updates.
Our Laboratories & Equipment
Our UX and medical usability labs provide the ideal environment for testing IFUs with real users. This allows us to observe whether users understand the steps involved, whether information is easy to find, and whether the IFU guides users safely through the process.
Through the observation room, you can follow the tests in real time without influencing the situation. Camera and audio equipment make it possible to reliably observe and document comprehension difficulties, uncertainties, and potential use errors.
If needed, eye-tracking can also be used to gain an even more precise understanding of what information users notice – and what details they might overlook. This provides reliable insights for the targeted optimization of your IFU.
Knowledge of IFU Design & Testing
From an intuitive information structure to testing with real users: Here you’ll find in-depth information on IFU design, IFU testing, and clear instructions for use for medical devices and IVDs.
Article
We want to get to know you and your product!
