Human Factors consulting for safe, effective, and compliant products.
Delayed approvals and costly redesigns due to non-compliance.
Expensive recalls damaging your brand reputation.
Potential harm to users leading to liability issues.
Loss of consumer trust and market share.
TMF provides comprehensive solutions to identify and mitigate these risks early in your development process, saving you time and money.
We specialize in preparing Human Factors documentation that meets rigorous regulatory standards, ensuring your submission is complete and compliant.
FDA Human Factors Guidance (2016)
ISO 14971 (Risk Management)
IEC 62366-1 (Usability Engineering)
Our reports are structured to meet regulatory expectations, including:
Through iterative design improvements based on human factors testing
After implementing our interface optimization recommendations
FDA clearance achieved without additional data requests
For a Class II medical device, we identified 22 use-related risks during formative testing. After redesign, summative testing showed zero critical errors with intended users.
Designing intuitive interfaces for complex medical workflows under time pressure
Validating driver interaction with infotainment and ADAS systems
Ensuring safety of medical apps used by consumers without training
Our team will help you navigate the human factors requirements specific to your product and development stage.
tmfchat@tmfhumanfactorsusabilityconsulting.com
+1 (640) 259-5957
9339 LASAINE AVE, NORTHRIDGE, CA 91325