We Design, Do, & Deliver Studies
Founded over twenty years ago, SoundRocket can meet your social science study needs in everything from design and data collection to analysis and reporting.
Your Research Partner in Precision & Execution
Expert project management, clear communication, and scientific rigor—SoundRocket integrates seamlessly with your team to keep studies on track. We specialize in two areas:
Regulatory Studies
SoundRocket specializes in regulatory studies that support successful 510(k) submissions with scientifically sound, defensible research. Call us when you need your next…
- Label Comprehension Study
- Self-Selection Study
- User Comprehension Study
- Human Factors Study
- Actual Use Study
- Simulated Used Study
- ACNU Study
- Consumer Study
- Provider Study
- Custom Study
Academic Studies
SoundRocket partners with researchers to design and execute high-quality social science studies using proven survey methodologies. Bring a Survey Methodologist and expert Survey Manager to your next…
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944
AncestryDNA Saliva Collection Kit
K192947
AlphaID At Home Genetic Health Risk Service
K221420
FERTI-LILY Conception Cup
K222969
GlutenID Celiac Genetic Health Risk Test
K241456
Select FDA Clearances
We design and implement science-guided, defensible studies that are targeted, rigorous, and led by experts.
We just got clearance from the FDA for the AlphaID At Home Service for OTC use!
USER COMPREHENSION STUDY Genetic Health Risk Test
SoundRocket Customers
SoundRocket has served over 400 institutions and organizations since 2004.
From the Launchpad
Navigating the Evolving Landscape: Risk Analysis and Human Factors in AI-Enabled Medical Devices
The integration of Artificial Intelligence (AI) and Machine Learning (ML) into medical devices is revolutionizing healthcare, unlocking unprecedented opportunities in diagnostics, treatment, and patient care. Yet this swift technological advancement introduces complex...
FDA Guidance on Human Factors and Usability Engineering for Medical Devices
Human factors studies and usability engineering are critical elements in the safe, effective, and user-centered design of medical devices. These disciplines ensure that devices are intuitive, reduce the likelihood of use errors, and support positive patient outcomes....
FDA-Compliant Label Comprehension Studies for OTC Drug & Device Clearance
FDA-compliant label comprehension studies are a critical part of the U.S. Food and Drug Administration (FDA) clearance process for over-the-counter (OTC) drugs and medical devices. These studies help ensure that consumers can safely and effectively use nonprescription...
FDA Risk Analysis for Your Medical Devices: What You Need to Know Now
FDA Risk Analysis, including Use-Related Risk Analysis (URRA), is no longer optional—it’s essential for medical device compliance. This guide explains URRA, why it’s vital for FDA submissions, and how to initiate effective risk management early in device development....
Survey Design Best Practices: Creating Usable Surveys
What are Survey Design Best Practices? Survey design best practices are proven principles and guidelines that ensure a survey is user-friendly, inclusive, and scientifically sound. They include structuring questions in a logical,...
User Comprehension Study Supports FDA Clearance of a Direct-to-Consumer Celiac Disease Genetic Health Risk Test
Ann Arbor, MI – February 21, 2025 – SoundRocket, a leader in user comprehension research for regulated medical and diagnostic devices, is proud to announce its role in securing FDA clearance for the GlutenID Celiac Genetic Health Risk (GHR) Test (K241456), developed...