IN ONE SIMPLE SENTENCE
Integrating lifecycle risk management with safe, effective device use and human-factors evidence.
ISO 14971 · IEC 62366-1 · IEC TR 62366-2
Risk and usability are connected but distinct controlled processes.
What is this service?
A device may function correctly while users still make mistakes because of poor design, unclear instructions or a confusing interface. Human factors examines how people interact with the device.
GOAL
Reduce use errors and help doctors, operators, patients or caregivers use the device correctly and safely.
What can MICT do here?
Define use scenarios, identify critical tasks, design usability tests, observe users and analyze use errors.
TYPICAL INPUTS
What we usually need to start
- User types
- Use environment
- Device user interface
- Instructions for Use (IFU)
- Risk analysis related to use errors
TYPICAL OUTPUTS
What this stage can deliver
- Use scenarios
- Critical-task list
- Usability test report
- Recommendations for interface or IFU improvements
- Human-factors evidence for the technical file
Important terms in plain language
Usability
How easily and effectively the product can be used with minimal error.
Human Factors
Study of the interaction between people, the device and the use environment.
Critical Task
A user task that could cause harm if performed incorrectly.
IFU
Instructions for Use; the official instructions supplied with the device.
Use Error
An error during use that may relate to design, training or the use environment.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
If older users position the cuff incorrectly, readings may be wrong. Usability testing helps determine whether the problem is training, cuff design or the instructions.