Usability Engineering / Human Factors Regulatory Pack

This provides a full pack of Usability Engineering files with compliance to ISO 62366-1 and associated guidance. This includes integration with ISO 14971, which is not available elsewhere and can be a missing step for some organisation until they meet the regulators! We also provide a usability template for AI-enabled Medical Devices / Health Software as well as Transparency and Explainability Evaluation Work Instruction. You won't find this anywhere else!

This pack contains:

• Usability Engineering Plan Template
• Usability Engineering Summary Report Template
• Usability Engineering Process SOP
• Usability Engineering for AI SOP
• Use Specification Template
• Use Error Analysis Template
• Formative Evaluation Plan & Report Template
• Summative Evaluation Plan & Report
• Usability File Index Template
• AI Usability Assessment Template
• Use Specification Work Instruction
• Formative Evaluation Work Instruction
• Summative Evaluation Work Instruction
• AI Transparency & Explainability Evaluation Work Instruction