IVD: Usability in the development process

The usability of IVDs is an important component of patient safety, efficiency in the use of the products as well as user satisfaction. As an IVD manufacturer, you are responsible here for the necessary activities related to usability according to IEC 62366-1 for all IVD products.

The usability process for medical devices described in IEC 62366-1 is therefore closely intertwined with the risk management process and shows the requirements for analysis, specification, development as well as verification and validation of usability. Our usability team knows all these requirements and supports you in creating the required usability file and integrating it into your development process.

We as Metecon are your competent partner for the creation of the required usability file and its integration into your development process. Put us to the test! Try us out!

'Suitable for use':
How much it takes until a product meets this
We will be happy to answer these and other questions during your free introductory meeting.

Our tip

In practice, it is advisable to consider whether usability investigation activities can possibly be linked to PMS activities in the context of performance evaluation.

Dr. Sandra Reuter - Team Lead IVD

Dr. Sandra Reuter

Team Lead IVD

Usability studies

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.

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 products that were already placed on the market before the introduction of IEC 62366-1 (legacy system), we prepare the suitability for use file for a fixed price, provided all the necessary documents are available.

Our usability team has the necessary experience to efficiently support you in the process accompanying the development. Furthermore, we have the right partners for planning and conducting your studies.

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.

Fit for today, fit for the future!

Our workshops give you the competence you need and help you master your current challenges. Let us find out together what you really need. Our expert workshops are always sustainable and individually tailored.

Get more information now