Usability Engineering: accompanying documentation that works
IFUs your users will want to read
The instructions for use and other accompanying documents are, by definition, part of the user interface of a medical device. Accordingly, they are subject to the requirements of the usability engineering process, just like the medical device itself. However, not everyone tasked with writing these documents actually knows the specific requirements.
Accompanying documentation is an integral part
Since the current regulations and standards for medical devices have placed greater focus on the information for use, special attention must be paid to the creation and evaluation of these documents.
Instructions for use that are correct in content and user-friendly have a positive influence on the safe operation of the medical device and on the user experience.
These are essential points to consider when creating user-friendly instructions for use:
Use-Lab has experience evaluating instructions for use taking into account regulatory requirements for medical devices, such as the IEC 62366, the Medical Device Regulation or the IEC 82079 series. Our participation in the Advisory Board for Law and Standards of tekom, the Society for Technical Documentation, means that we are always up to date on current requirements.
We evaluate the accompanying documents at an early stage and involve the users in the evaluation phases accompanying the development. We work closely with our customers’ technical writers and support our customers in their goal of developing target group-oriented and understandable user information.