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!

Our experienced team can help you tailor these to your device and organisation, contact us at: www.stjohnlynch.com

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