Human Factors/Usability Services:

• Regulatory strategy related to HF/Usability

• Successful responses to FDA HF deficiencies

• Use related risk analyses (URRA) that have been well received by FDA and guides usability activities

• Summative usability validation studies that prove risks are adequately mitigated and meet requirements

• Formative studies and analytical activities that lead to safe design and successful validation studies

• HFE/UE reports for FDA submissions

Marketing Services:

• User needs development and confirmation, focus groups, ethnographic inquiries, contextual inquiry, strategy, clinical messaging…