Loring Human Factors, Inc.

Loring Human Factors (LHF) is a specialized consultancy focused on human factors engineering, usability research, and intuitive design for healthcare and medical device companies. The firm helps device manufacturers navigate regulatory processes for FDA and CE Mark submissions through comprehensive human factors testing and documentation.

LHF's services span the complete product lifecycle, from ideation and concept selection through validation testing, reporting, and regulatory submission. The team provides use-related risk analysis (URRA), formative and summative usability studies, expert reviews, instruction for use (IFU) design, and wireframe development. Their approach combines regulatory compliance expertise with user-centered design principles to help clients develop safe, intuitive medical devices.

The firm has worked across diverse medical device categories including robotic surgery systems, spinal navigation systems, infusion systems, blood chemistry analyzers, ventilators, and wearable biosensors. Notable engagements include supporting Bolt Navigation's FDA approval for their spinal navigation system and conducting usability studies for established companies like Vapotherm and Hologic.

Choose Loring Human Factors when you need specialized regulatory human factors expertise for a medical device FDA or CE Mark submission. Their comprehensive approach to usability engineering and risk analysis is particularly valuable for companies developing complex medical devices, surgical systems, or novel healthcare equipment where rigorous validation is critical to approval.

Expect a structured engagement that follows regulatory frameworks closely, with deliverables explicitly designed for submission packages. Their experience supporting startups through first approvals suggests they can guide companies unfamiliar with regulatory human factors requirements.

Loring Human Factors operates exclusively within the medical device and healthcare equipment sector, with specialization in regulatory compliance for FDA and international markets. Their expertise centers on medical device-specific requirements including use-related risk analysis, IEC 62366 compliance, and human factors validation studies tailored to regulatory submissions.

The firm works across multiple medical device verticals including surgical equipment, critical care systems, drug delivery devices, diagnostic equipment, and combination products. Their understanding of regulatory body expectations for human factors documentation positions them specifically for companies navigating medical device approval processes.

Medical device manufacturers in development or pre-submission phases who need human factors engineering support to meet FDA or CE Mark requirements. Companies with Class II or Class III devices requiring formal usability validation, particularly those developing surgical systems, patient monitoring equipment, drug delivery systems, or other complex medical devices where use-related risks require rigorous analysis and testing.