Instructions for Use & Training Materials
We assist you in the process of developing your Instructions for Use (IFU), user manual, and training materials. According to the FDA, these materials are considered part of the user interface, and they must be treated with as much care as the device itself.
In the EU, with few exceptions, IFU must be provided in all languages of the member countries where the product is marketed. Numerous standards impose further specific requirements on IFU. Furthermore, the MDR, as well as the IVDR, require the provision of product-specific training, should this be necessary for the safe use of the product. Product-specific training materials can also make a significant difference in the safe, efficient, and effective use of medical devices and IVDs.
In dozens of summative usability tests, we have observed usage errors due to inadequate instructions for use and training, potentially delaying product approval. In the worst case, if your product is already on the market, it may even result in recalls due to serious usage errors.
Johner Institute’s experts will be happy to assist you in the process of developing the IFU and training materials to promote user success. We also test IFU and training designs using various formative evaluation methods, to check whether your documentation and training are a real help to the intended users.
We offer a variety of services to aid your IFU and training, including:
- Checking whether you need IFU or training for your product at all and whether the provision of electronic instructions for use is an option
- Helping to create a lean development and document control process for IFU, user manuals, Quick Start Guides, and training materials
- Providing you with guiding templates and checklists for the creation of IFU and training materials that comply with laws and standards
- Reviewing your IFU for compliance with the MDR/IVDR and other relevant standards and making suggestions for improvement, if necessary.
- Revising your IFU according to MDR/IVDR requirements.
- Reviewing your IFU and training material for comprehension and user-friendliness on the basis of design principles and, if necessary, making suggestions for improvement.
- Evaluating the comprehensibility of your IFU and training materials in the context of usability tests with intended users.
- Designing the textual content and/or layout of IFU and training materials.
- Having your documents translated for your target markets by qualified, experienced, and certified native speakers.
We are happy to assist you and coordinate the testing effort depending on the approval location (e.g. the US).