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
Summary Download CTA Test
See How Successful FDA Regulatory Studies Are Done Planning a 510(k) submission? Download real study summaries from SoundRocket to see how our research led to FDA clearance.User Comprehension Study AncestryDNA Factor V Leiden Genetic Health Risk TestLabel...
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...
Best Practices for Questionnaire Design
Introduction Questionnaire design is a cornerstone of survey research. It guides the development of questions, structures the survey, and ensures it achieves the intended research objectives. Strong design enhances the validity and reliability of the data collected in...
The Role of a CRO in Medical Device Regulatory Compliance
Navigating FDA regulatory compliance for medical devices is a multifaceted challenge that demands precision, expertise, and seamless collaboration. For medical device regulatory consultants and compliance-focused professionals, partnering with a specialized Contract...
Introducing a Specialized CRO for FDA 510(k) Study Needs
Introducing a Specialized CRO for FDA 510(k) Study Needs Bringing a medical device to market requires navigating complex FDA regulatory pathways for medical devices. These pathways—such as premarket notification (510(k)), premarket approval (PMA), and De Novo...
FAQs about the FDA’s Final Rule on ACNU for Nonprescription Drugs
What is ACNU? ACNU stands for "Additional Condition for Nonprescription Use," a regulatory framework introduced by the U.S. Food and Drug Administration (FDA) to make certain medications available over-the-counter (OTC) while ensuring they are safe and effective for...