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