FDA Human Factors Studies
Designing products that are safe, effective, and FDA-compliant requires more than just technical expertise—it takes a deep understanding of how real people interact with your innovations. At SoundRocket, we specialize in FDA Human Factors Studies, applying cutting-edge human factors testing and FDA guidance to deliver the insights you need to navigate the regulatory process with confidence and ease.
Addressing the Challenges of FDA Human Factors Studies
To obtain FDA 510(k) premarket authorization, your human factors study must meet the following:
FDA Regulatory Requirements
Complying with the FDA’s stringent requirements for human factors studies demands in-depth expertise and a thorough understanding of regulatory standards.
Rigorous Study Design
FDA human factors studies must have a rigorous, predetermined study design prior to launching. The protocol must include full study details, including the sample design, study methodology, and plans for study implementation.
High Quality User Data Analysis
Collecting and analyzing data for human factors studies requires sophisticated tools, advanced analytical capabilities, a solid grasp of statistical techniques, and a team with experience interpreting human factors data with an eye towards patient safety.
Streamlining FDA 510(k) Clearance with SoundRocket's Expert Human Factors Studies
Ensure your health risk product (e.g. drug, device or medical test) achieves FDA compliance and market readiness with SoundRocket’s specialized human factors studies. Our comprehensive and experienced approach, we:
Design and Execute Science-Guided Studies
Our team designs and implements rigorous, defensible, quantitative and qualitative human factors studies that meet FDA standards, ensuring precise and reliable outcomes.
Root Cause Analysis
SoundRocket conducts root cause analysis assessments to uncover underlying issues, providing actionable insights and solutions to enhance processes, reduce risks, and demonstrate adequate risk mitigation.
Develop Human Factors Study Materials
We create accurate, clear materials specifically tailored to facilitate user interactions and meet FDA requirements.
Facilitate FDA Communications
Our experts provide clear and effective communication for all FDA study-related inquiries, supporting you through all aspects of your human factors study.
End-to-End Project Management
From initial planning to a final study report that is FDA-ready for your 510(k) submission, we will help you conduct a smooth human factors study from beginning to the end.
Who Benefits from FDA Human Factors Studies?
SoundRocket’s FDA Human Factors Studies are perfect for
Medical Device Innovators
If your device requires FDA clearance, we’ll help ensure it meets usability and safety expectations.
Pharmaceutical Companies
For combination products, we’ll validate ease-of-use and identify potential user risks.
Research-Driven Organizations
Looking to deeply understand how people interact with your product? Our studies are grounded in behavioral science.
SoundRocket Co-Pilot Human Factors Studies
Co-Pilot is a proven 3-step approach to FDA Human Factors studies. It can be utilized for pre-market or post-market evaluations, in both moderated or self-administered formats, and is applicable to studies involving consumers or healthcare providers.
Prep It.
Optimize your product study protocols to ensure FDA compliance and success.
Create a study protocol tailored to meet the FDA’s rigorous expectations for human factors studies.
Pilot It.
Refine your product study methodologies through iterative testing.
Conduct user interviews to refine study protocols. Execute a pilot test of the finalized design before launching the full study.
Prove It.
Conduct comprehensive human factors studies to meet FDA requirements.
Run the study to gather data that aligns with FDA’s collection and reporting standards. Deliver a comprehensive, FDA-compliant study report.
Maintain It.
Ensure ongoing compliance and satisfaction through continuous improvement.
We recommend retesting either when significant changes have occurred or at least every 2-3 years, whichever comes first.
Our Self-Administered Studies Deliver Results
Regulatory Confidence
We help you produce FDA-ready reports that remove guesswork and prepare your product for submission.
Thoughtful Study Design
We design protocols that balance scientific rigor with real-world usability, so your study reflects how users truly interact with your product.
Actionable Risk Insights
Our analysis doesn’t just meet compliance—it reveals opportunities to make your product better, safer, and more intuitive.
Faster Survey Results
Collect results faster leading to shorter studies.
Lower Costs
Save on travel, administration, and recruitment costs.
Larger Sample Sizes
Dedicate more of your budget towards larger sample sizes.
Meet all FDA Requirements
Co-pilot is a perfect fit for FDA-grade studies.
SoundRocket stands as your trusted ally in achieving excellence in survey research.
With our unwavering dedication to perfection and ensuring your satisfaction, we present unmatched services tailored to precisely meet your research requirements with the utmost professionalism.
Methodological Expertise
We have deep knowledge to design rigorous, effective user comprehension studies.
Collaborative Approach
Work closely with our team for tailored solutions and successful project outcomes.
Customization and Flexibility
Bespoke study designs that adapt to your unique product and regulatory needs.
Attention to Detail and QA
Meticulous quality assurance ensuring accurate and reliable results.
Ethical Standards & Privacy
Commited to ethical practices and stringent data privacy protections.
Timely and Responsive
Experience prompt, reliable communication and swift project execution.
Key to our success with these studies is our strong relationships with research facilities, reliable expert participant recruiters, and moderators with human factors expertise
Comprehensive Human Factors Studies for Seamless FDA 510(k) Clearance
Study Planning, Design, & Management
Study Implementation
Analysis & Scholarly Reporting
Thorough analysis and detailed reports meeting FDA standards for clear, actionable results.
Frequently Asked Questions
What is the purpose of FDA Human Factors Studies?
FDA Human Factors Studies are essential for ensuring your product is safe, effective, and ready for FDA approval. These studies focus on how users interact with your medical device or combination product, identifying potential errors and usability challenges that could impact safety or effectiveness. With SoundRocket, you’ll have the confidence of knowing your product meets FDA standards and exceeds user expectations.
How does SoundRocket ensure FDA-compliant Human Factors Studies?
Our team designs every study to align with FDA human factors guidance, combining rigorous scientific methods with real-world usability testing. We follow FDA standards for data collection, root cause analysis, and risk mitigation, providing tailored solutions for your specific product. Whether you’re working on medical devices or combination products, we’ll ensure your study meets all regulatory requirements and exceeds expectations.
What types of products require Human Factors Studies?
Human Factors Studies are required for medical devices, combination products, and any innovations where user safety is critical. Common examples include drug delivery systems, diagnostic tools, and surgical instruments. SoundRocket specializes in tailoring studies for these products, ensuring they meet FDA requirements and are optimized for real-world use.
Client Successes
We just got clearance from the FDA for the AlphaID At Home Service for OTC use!
USER COMPREHENSION STUDY
Genetic Health Risk Test
I will be sure to recommend SoundRocket to others seeking approval in the US.
LABEL COMPREHENSION STUDY
EU Medical Device Granted US FDA Clearance.
This morning, we got FDA clearance for both products! Thank you so much for getting us to this point
USER COMPREHENSION STUDY & ACTUAL USE STUDY
Genetic Health Risk Test & Saliva Collection Kit
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