IEC 62366 Usability Engineering Assessment

Evaluate medical device usability engineering per IEC 62366-1:2015, covering user interface design, formative and summative usability testing, and use-related risk analysis

MedtechHealthcareBiotech25 minutes20 questions

1. Usability Engineering Process

Have you established a usability engineering process per IEC 62366-1?*

Clause 4: Systematic process integrated with risk management and design

Is a usability engineering file maintained throughout development?*

Clause 4.1.2: File documents all usability engineering activities

Have you identified intended users, use environments, and use scenarios?*

Clause 5.1-5.3: User profiles, environments, tasks define context of use

Have user needs been identified and documented?*

Clause 5.4: User needs inform requirements and design

2. User Interface Specification

Is a user interface specification created describing all UI elements?*

Clause 5.5: Specify display, controls, alarms, warnings, errors

Are use-related hazards identified through risk analysis?*

Clause 5.6: Identify use errors that could lead to hazardous situations (ISO 14971)

Have you identified critical tasks and user interface elements contributing to safety?*

Clause 5.7: Prioritize safety-critical UI elements for validation

3. Formative Evaluation

Do you conduct formative usability evaluations during design?*

Clause 5.8: Iterative testing identifies and resolves usability issues early

Are formative evaluations conducted with representative users?*

Clause 5.8: Test with users matching intended user profiles

Are formative findings used to improve user interface design?*

Clause 5.8: Iterate design based on usability issues identified

4. Summative Evaluation

Is summative usability testing performed with final or near-final design?*

Clause 6: Summative evaluation validates UI safety and effectiveness

Does summative testing include all critical tasks in realistic use scenarios?*

Clause 6.1: Test safety-critical UI elements in simulated use environment

Are summative test participants representative of intended users?*

Clause 6.2: Sample size and user characteristics per statistical justification

Is summative testing conducted by personnel independent of design team?*

Clause 6.1: Independence reduces bias in evaluation

5. Use-Related Risk Analysis

Have you analyzed use errors observed in testing for potential harm?*

Clause 7: Integrate use error analysis with ISO 14971 risk management

Are use-related risk control measures implemented and verified?*

Clause 7.1: Design changes, protective measures, information for safety

Is residual use-related risk acceptable and disclosed to users?*

Clause 7.2: Document risk acceptability and inform users of residual risks

6. Usability Validation

Does the usability validation report demonstrate safe and effective use?*

Clause 8: Report confirms UI design meets safety and usability objectives

Are instructions for use (IFU) validated for comprehension and usability?*

Best practice: Test IFU readability and effectiveness with users

Is post-market usability data collected and reviewed?*

Clause 9: Monitor use errors and complaints for continuous improvement

Please answer all required questions to see your results