Ergonomics and usability in medical engineering are important aspects for patient safety, for the efficient application of medical devices, as well as for satisfied medical device users. As a manufacturer of medical devices, you are responsible for all necessary activities relating to usability in accordance with IEC 62366-1 for all medical devices and with IEC 60601-1-6 for medical electrical equipment.As many incidents with medical devices result from a lack of usability, their user interfaces must fulfill special requirements.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 standards 60601-1-6, IEC 62366-1, and IEC 62366-2. For developing the required usability file and integration into your development process we are your competent partner. Put us to the test!
In practice, we recommend to check whether the activities for examining the usability might be combined with the PMS activities of Clinical Affairs.
In usability studies, also called summative evaluation, real users interact with one or more models of medical devices, with prototypes or samples of ready manufactured medical devices 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 persons is rather small, failures with a low probability of occurrence cannot be detected. 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 initially without any obligation!
Usability engineering file
The usability engineering process covers the entire product development and significantly supports your development engineers. The results are documented in the usability engineering file, which you as the distributor need to provide to document the usability of your 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 validation 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 legacy systems put into service before IEC 62366-1 took effect, we develop the usability engineering file at a fixed price, provided that all required documents are available.
Our usability team has all the required experience to support you efficiently in the development-related process; furthermore, we work with relevant 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.
Facing challenges with a smile
True, the requirements for you as a manufacturer are enormous: The EU agrees on a new medical device regulation (MDR) in nearly no time and leaves manufacturers with an interim period of no more than three years to lift all medical devices to MDR level. MEDDEV 2.7/1 revision 4 increases the planning pressure on manufacturers: The notified bodies call for updated clinical evaluation already. And the ideas for software as a medical device often seem to be well ahead of its documentation. Knowing that there is a partner at your side with comprehensive know-how and many years of experience with the documentation and approval of medical devices and IVDs along with their verification and validation, there is no need to worry. We are committed consultants and service providers. Together we make your project a success.We look forward to getting to know you!