Specialized CRO for FDA Human Factors and Regulatory Studies
Focused expertise in human factors for usability and 510(k) regulatory studies.
What is a Human Factors Contract Research Organization (CRO)?
The key difference between a general CRO and one focused on Human Factors lies in their scope of services. General CROs offer a broad range of research services, including clinical trials and studies across various therapeutic areas.
In contrast, a Human Factors CRO specializes exclusively in usability and human factors studies, ensuring medical devices meet FDA requirements for safe and effective use. This laser-focused expertise makes Human Factors CROs invaluable for 510(k) submissions.
Are you a Contract Research Organization? Learn more about partnering with SoundRocket.
SoundRocket Human Factors Studies for Medical Device 510(k) Premarket Authorization
We provide a full range of human factors studies—user comprehension, self-selection, simulated use, and label comprehension—to ensure your medical device meets FDA requirements.
Label Comprehension
Helping users understand critical product information.
Label comprehension studies test if users can understand and correctly interpret the instructions and information on a product’s label. This ensures users can apply the information on the label to use the device safely, effectively, and as intended.
Self-Selection Studies
Supporting Independent User Decision-Making
Self-selection studies check if users can decide on their own whether a product is right for them. These studies are important for over-the-counter devices where users don’t have guidance from a doctor. They show the product is safe for independent use.
User Comprehension
Ensuring Users Understand Your Product
User comprehension studies evaluate how well typical users understand a direct-to-consumer (DTC) health product’s test report and supporting materials. FDA user comprehension studies are required for DTC genetic health risk test 510(k) submissions.
Simulated Use Studies
Recreating Real-World Conditions for Safety and Usability
Simulated use studies test how users interact with a medical device based on the instructions for use. These studies help identify problems with the usability of the device or comprehension of the device instructions to ensure users can safely use the device on their own.
Additional Support for Seamless 510k Clearance
FDA Submission Support
We create detailed reports and documentation to helps ensure your medical device meet FDA study requirements for 510(k) submissions. Our work ensures your submission is clear and complete.
Regulatory Communication
We assist with all communication related to FDA studies, making sure your responses are accurate and align with regulatory expectations.
End-to-End Project Management
From start to finish, we manage every part of your project to keep it on track and compliant with FDA standards.
Why Choose a Specialized CRO for Medical Device Regulatory Studies?
Specialized 510(k) Knowledge
Expertise tailored to the unique requirements of FDA 510(k) submissions for medical devices.
Custom Studies
Tailored research methodologies that address your device’s specific usability and regulatory needs.
Reduced Complexity
Streamlined processes to simplify the path to authorization and eliminate unnecessary hurdles.
Faster Go-to-Market
Prevent unnecssary delays caused from improperly designed or executed studies.
FDA Clearances
Products We’ve Supported in Achieving FDA 510(k) Clearance
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944
AncestryDNA Saliva Collection Kit
K192944
AlphaID At Home Genetic Health Risk Service
K192944
FERTI-LILY Conception Cup
K192944
GlutenID Celiac Genetic Health Risk Test
K241456
Talk to Our Specialists
Discover how SoundRocket’s targeted CRO services can streamline your FDA 510(k) submission.
What Our Customers Are Saying
What our clients have to say about their experiences with SoundRocket
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
Frequently Asked Questions
What makes SoundRocket different from a traditional CRO?
SoundRocket is not a full-service CRO but a specialized partner focused exclusively on FDA 510(k) regulatory studies, including human factors, usability, safety, and effectiveness of medical devices. Unlike traditional CROs that handle clinical trials and a broad range of research services, we concentrate on the studies needed to demonstrate usability, safety, and 510(k) acceptance for medical devices.
How does SoundRocket support the 510(k) submission process?
We will help you meet the FDA’s rigorous expectations for 510(k) regulatory studies. We will design, conduct, and provide a report formatted to easily integrate into your 510(k) submission.
How does SoundRocket's specialized CRO approach benefit my 510(k) submission timeline?
Compiling all elements for an FDA 510(k) submission takes time. We take care of your FDA study from design to reporting. Our methodology involves pilot work at the outset and has an extremely high success rate. You will be able to easily integrate our study report (formated to meet FDA requirements) into your 510(k) submission.
Does SoundRocket do clinical trials?
No, SoundRocket does not conduct clinical trials. We specialize in non-clinical studies that are critical for FDA 510(k) submissions, such as human factors and usability research. By focusing on these areas, we complement traditional CROs that handle clinical trial services.