Meet Co-Pilot, your pathway to FDA 510(k) approval.
SoundRocket is your trusted partner for seamless FDA 510(k)-ready human factors studies.
The Co-Pilot Process
Co-Pilot is an established 3-step approach to FDA studies. It can be pre-market or post-market studies, moderated or self-administered design, with consumers or healthcare providers. As your co-pilot, we can adapt a custom solution to meet your study needs.
Prep It.
Optimize your product label or test report for success.
Design a study protocol to meet the FDA’s expectations.
Pilot It.
Refine product labeling and study protocols based on user interviews.
Pilot test the final design before launching full study.
Prove It.
Run the study to meet FDA’s data collection and reporting needs.
Deliver an FDA-ready study report.
Maintain It.
Ensure ongoing compliance and satisfaction through continuous improvement.
Keep your product in line with regulatory changes and maintain customer satisfaction. Efficiently conduct follow-up studies when regulations change, products are updated, or user feedback is collected.
Comprehensive Support for FDA Approval
With SoundRocket’s Co-Pilot Program, we provide a full suite of services to ensure your product meets FDA standards and achieves market readiness. Our expertise covers every aspect of the approval process, from content creation to final submission. Our services include:
- Creating, designing, and editing health-related content
- Designing and implementing FDA-grade studies
- Developing reports for an FDA submission
- Supporting study-related FDA communications
- Providing end-to-end project management
Meet the Experts Behind SoundRocket's Co-Pilot Program
At SoundRocket, our Co-Pilot Program is driven by a team of highly skilled professionals, each bringing specialized expertise to ensure the success of your FDA approval process. Our diverse team includes:
- Survey Methodologists
- Science Writers
- Genetic Counselors
- Project Managers
- Programmers
- Data Analysts
SoundRocket CO-Pilot Studies
We design and implement science-guided, defensible studies that are targeted, rigorous, and led by experts.
Label Comprehension Studies
Evaluate user understanding and interpret product labeling information.
User Comprehension Studies
Asses user understanding and retention of key information from provided materials.
Self-Selection Studies
Determine if users can correctly decide if a product is appropriate for their use.
Simulated Use Studies
Test user interaction with a product in a controlled environment to mimic real world usage.
Human Factor Studies
Examine how users interact with a product to ensure it is safe, effective, and user-friendly.
Not sure? We can help.
If you’re unsure which study to choose, SoundRocket’s experts can help you decide.
FDA Clearances
We design and implement science-guided, defensible studies that are targeted, rigorous, and led by experts.
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
What our customers are saying
Discover what our clients have to say about their experiences with SoundRocket’s expert services.
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
Let us help you get unstuck and tackle your next project successfully
