World Class Human Factors & Usability Engineering Expertise
We provide exceptional Human Factors and Usability Engineering solutions in healthcare technology
Meet with an Expert
Ensuring product safety and compliance isn’t just optional— it’s a necessity.
If your medical technology is recognized as potentially hazardous or high-risk, you’re likely navigating complex federal regulations, including the FDA’s stringent guidelines. We assess the risks associated with your product and provide targeted solutions to not only meet regulatory standards but to make your product safer and more user-friendly. Here are some common issues you may be experiencing:
Confusing or non-compliant product labeling
Overwhelming FDA requests for additional information
Disorganized document control systems
Lack of human factors understanding
Our Solutions
Human factors play a crucial role in health tech design.
We offer comprehensive training to help your team understand and implement human factors considerations, ensuring your products are not only compliant but optimized for safe, effective use.
Human Factors & Usability Engineering Strategy
Create tailored strategies for your device and guide you through each phase of the process.
Formative & Summative Study Design & IRB Preparation
Handle URRA development, recruiting, and documentation, ensuring smooth and compliant testing.
Human Factors SOP Development & Documentation Review
Establish best practices with customized Standard Operating Procedures (SOPs) and ensure your documentation.
Post-Market Human Factors Assessment
Ensure ongoing product safety and usability post-launch with assessments like user surveys, incident reports, and iterative improvements based on performance data.
Regulatory Response & Labeling Assistance
Expert help in responding to FDA and EUMDR requests, including information and clarification requests.
Risk Management & Compliance Support
Comprehensive risk management services, including uFEMAs and URRAs, to address safety concerns and meet compliance standards throughout the product lifecycle.
We have maintained a 100% success rate with FDA approvals for human factors submissions.
Benefits of working with an outside consultant vs an internal team or process:
Internal Teams
Unfamiliar with complete HF/UE Process and activities
Limited resources often hinder ability to fully address all human factors responsibilities
Limited capabilities and solutions
Lengthy review processes
vs
Human Factors Strategies
Gain valuable, objective insights that uncover opportunities and mitigate risks others might miss.
Increased Efficiency & Expanded resources
Flexibility and greater capabilities
Our experienced reviewers ensure accurate and efficient document review, saving you valuable time
How It Works
Consultation call
Schedule a strategy call where we dive deep into your product needs, challenges, and goals to ensure we understand your requirements fully.
/ 01
Strategy & Proposal Development
Based on our discussion, we’ll craft a detailed plan and strategy tailored to your specific project needs. You’ll receive a formal proposal outlining our approach and deliverables.
/ 02
Agreement Finalization
Once the proposal is approved, we’ll formalize the agreement, setting clear expectations for timelines, responsibilities, and next steps.
/ 03
Delivering innovative, safe, and user-centered healthcare technologies.
Our team has years of medical technology development and consulting experince.
Who We Are
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