Human Factors Capabilities Noble's Human Factors Plus Capabilities Include: Consultation Assess the device risks and define user groups to formulate a regulatory study and submission plan. Risk Assessment Collaborate with the client to analyze user data and generate the requisite risk assessment documents. Formative Studies Define the studies needed to collect critical inputs from statistically valid user groups. HF Validation Studies Protocol development and execution for the Human Factors Validation Study for regulatory submission Submission Report Collaborate with client's regulatory teams to draft the Human Factors Submission Report and support the client with regulatory queries.
