Clinical Input
Clinical Input is a company dedicated to bringing technology to the market faster and safer, specializing in human factors and usability services for medical technology. They offer regulatory strategy, FDA response success, risk analyses, usability validation, and reports for FDA submissions, along with marketing services such as user needs development and clinical messaging.
Industries
Nr. of Employees
small (1-50)
Clinical Input
125 S. Hwy 101, Suite 1080, Solana Beach, California 92075
Services
Consulting services covering regulatory strategy, formative and summative usability studies, use-related risk analyses, and preparation of HFE/UE reports for regulatory submissions.
Preparation of responses and corrective plans addressing FDA human factors deficiencies identified during regulatory review.
Execution of use-related risk analyses to prioritize hazards and guide usability test planning and design changes.
Design and conduct of formative studies to refine design and summative validation studies to demonstrate mitigated use-related risks.
User needs development, focus groups, ethnographic inquiries, contextual inquiry, and clinical messaging to inform product strategy and communications.
Consulting services covering regulatory strategy, formative and summative usability studies, use-related risk analyses, and preparation of HFE/UE reports for regulatory submissions.
Preparation of responses and corrective plans addressing FDA human factors deficiencies identified during regulatory review.
Execution of use-related risk analyses to prioritize hazards and guide usability test planning and design changes.
Design and conduct of formative studies to refine design and summative validation studies to demonstrate mitigated use-related risks.
User needs development, focus groups, ethnographic inquiries, contextual inquiry, and clinical messaging to inform product strategy and communications.
Expertise Areas
- Human factors and usability engineering
- Regulatory strategy for medical devices
- Use-related risk analysis
- Usability validation (summative) studies
Key Technologies
- Usability testing (formative and summative)
- Use-related risk analysis (URRA)
- Human factors engineering methods
- Contextual inquiry