Plan the entire usability process to be put in place according to the device

Identify the different user profiles as well as the different contexts of use.

Identifying known or foreseeable hazards and dangerous situations is part of the risk management process as described in ISO 14971. It is therefore necessary to describe the use scenarios relating to the dangerous phenomenon that represent the way in which the user uses the medical device and which leads to an error in use. The risk analysis should then be updated throughout the process.

(digital interfaces, products, packaging, instructions, etc.) by integrating the control of risks associated with use
‍
Usability goals | Models | Ergonomic specifications | User manuals | Graphic design (UI design) | Ergonomic graphic charter

Describe the methods that will be used to assess the device and the evaluation criteria. Plan formative and summative evaluations

Definition of criteria | Project team agreement

Identify during the design the strengths and weaknesses of the device as well as the unanticipated risks of use. Implement improvements.

Expert Assessment | User Testing | Design Audit

Evaluation of the final device providing proof that its ergonomics are optimal.

Interviews | In-situ observation | Expert audit | Expert audit | Focus group | User tests (real or simulated situation)

Summary of the ergonomic approach that has been applied. This summary is then integrated into the risk management file.

Summary of the approach | Risk presentation | Assessment results | Conclusion on suitability for use

Identification of the strengths and weaknesses of the device as well as the risks of use that were not anticipated during the design.

Analysis of real uses | Adjustment of risk analysis | Proactive approach | Conclusion with respect to suitability for use