Services offered by Dr. Israelski
Human Factors Consulting for Medical Product Development
Strategic advice consulting especially for medical products regulatory approval
Advice on Human Factors Engineering HFE project plans (methods, budget and timelines)
Review and critique: User Interface design plans, Contextual Inquiry protocols, Risk Analysis including Use Related Risk Analysis and Use Failure Modes Effects Analysis,
Formative and Summative Usability Tests: Plans, Protocols, Moderator Guides, Observation of testing sessions, Data Analysis and Root Cause Analysis, Reports for regulatory bodies e.g. FDA, EMA, HFE/Usability Engineering Summary Reports
Assist in answering Regulatory questions and information requests
Help prepare briefing materials and attend regulatory review meetings
Expert Witness for Human Factors Engineering
Case Review and Root Cause Analysis
Develop questions for Discovery, Depositions and Trials
Conduct human factors studies to present data at trial
Literature reviews
Site Visits
Interviews
Develop Expert Reports
Give Depositions
Testify at Trials