An optimally designed user interface between human being and medical device or stand-alone software is the foundation for handling medical devices efficiently and safely. Closely dovetailing usability engineering and risk management is in this context prerequisite to develop usable medical products that ensure a high level of patient safety. In medicine, excellent usability and good software ergonomics can save lives — since they reduce in particular those accidents that result from simple operator errors.
IEC (International Electronic Commission) 60601-1-6 and IEC 62366 define a consistent framework for ensuring usability in the medical sector. These standards stipulate the early involvement of users, a structured UI design process and specific documentation formats for the development of medical devices and in-vitro-diagnostics. Moreover, by maintaining a close connection to risk management you ensure a high basic level of safety. We offer comprehensive validation process support and will advise you on how to prepare the required usability engineering files.
Increasing user variety
The increasing variety and application potentials of medical products also increase the circle of potential users. Today, the use of medical appliances is not restricted to qualified healthcare professionals anymore – patients and their family members form a central user group, too, e.g. in telemedicine applications. The easily comprehensible, accessible and risk-minimized operation of medical products is thus an increasingly important requirement.
We profoundly support your way to the standard-compliant development of medical products and detailed documentation. In this course, our special focus is on mutually creating innovative solutions that make working with your product more efficient – and human lives safer:
- versatile project experience with respect to medical products
- extensive user pool (physicians, lab staff and qualified medical personnel)
- long-standing experience with various input units (from film to multi-touch)
Indisputably professional Ergosign team created very appealing and well-thought-out modern UI for our medical device, although they were put on tight schedule and needed to keep their work aligned with another team who were creating design of the device in parallel. ”