The usability of IVDs is an important aspect for patient safety, for the efficient application of the devices, as well as for satisfied users. As a manufacturer of IVDs you are responsible for all necessary activities relating to usability in accordance with IEC 62366-1 for all IVD medical devices.The process for the usability of medical devices described in IEC 62366-1 is therefore closely linked to the risk management process and specifies the requirements of the analysis, specification, development, as well as verification and validation of usability. Our usability team knows all of these requirements and supports you in developing the required usability file and its integration into your development process.Metecon is a member of the committee “DKE/UK 811.4 ergonomics, usability, instruction manual” concerning the 60601-1-6, IEC 62366-1 and IEC 62366-2 standards. For developing the required usability file and integration into your development process we are your competent partner. Put us to the test!
In practice, it is recommendable to check whether the activities for examining the usability might be combined with the PMS activities in the context of performance evaluation.
In usability studies, also called summative evaluation, real users interact with prototypes or pilot batches to assess the learning conduciveness, simplicity of use, efficiency, memory conduciveness and/or attractiveness for the user.Usability studies may be conducted in a laboratory environment, in a simulated environment, or in the real environment of the intended use. In particular when conducted as field studies, they are able to reveal user errors. However, as the number of test users is small, errors with a low probability of occurrence can only be detected very rarely; therefore, the application of additional techniques, such as risk analysis, is essential.Together with our partners we support your planning and design of your usability study. We filter the requirements for your usability study from the technical documentation and in turn integrate the results into the technical documentation. Just contact us to discuss your needs without any obligation!
Usability engineering file
The usability engineering process covers the entire product development and significantly supports your development team. The results are documented in the usability engineering file, which you as the distributor need to provide to document the usability of your IVD medical device.The analysis phase analyzes and documents the requirements of the different user groups and usage environments. The results are adopted into the product requirements and are therefore available to the developer. Continuous tests and inspections of usability at different development stages (formative evaluation) of the product examine whether the development process is targeted. This avoids expensive loops in the development process, which is important not only but especially for software developments. The validation stage examines and verifies whether the requirements in terms of usability are met.For existing products that are already in the market, the process is different: In most cases, instead of conducting a study, incidents and failures of the device and comparable competitive devices may be analyzed and this analysis may then serve as proof of fulfilling usability requirements. The usability engineering file, however, follows the same outline and structure as in case of a new development.For devices put into service before IEC 62366-1 took effect (legacy systems), we develop the usability engineering file at a fixed price, provided that all required documents are available.
Our usability team has the necessary experience to efficiently support you in the process accompanying the development. Furthermore, we work with the appropriate partners for planning and conducting the study.Contact us
Our services all around your usability engineering file
- Developing the usability engineering file,
- Aligning the content with the risk management file,
- Organizing and involving usability experts for conducting customer surveys and validation studies,
- Training and consulting how to implement the requirements of IEC 62366-1 in practice.
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