…to precisely meet your research requirements with the utmost professionalism. We have deep knowledge to design rigorous, effective user comprehension studies. Work closely with our team for tailored solutions and…
Results for "user comprehension"
Research Wonder: DNA with a bow on it, a gift that may (unexpectedly) ‘keep on giving’
… The FDA oversees DTC GHR products. An important part of the FDA authorization process is user comprehension. They require test manufacturers to conduct user comprehension studies—demonstrating that the…
Helix enters DTC game with broad whole exome sequencing platform
…the company, and comprehension of test materials through user comprehension studies. The Helix Laboratory Platform The Helix Laboratory Platform (HLP) was submitted as a data generation tool only, with no clinical or interpretation…
FDA Simulated Use Studies
…user risks. Test user interactions and ensure compliance with FDA usability standards. We’ve developed a tested and proven approach called Co-Pilot (Comprehension Pilot) for FDA simulated use studies. Our team…
The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)
…materials) can be understood by a consumer without the involvement of a healthcare provider. This is done by conducting a user comprehension study. Now that you know some 510(k) basics,…
Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!
…located in Ann Arbor, Michigan. He is trained as a Survey Methodologist (University of Michigan, 2000) and has been involved in user comprehension research (among other fields) for government, academic…
Navigating the FDA’s Final Rule on ACNU for Nonprescription Drugs
…how our research led to FDA clearance. User Comprehension Study AncestryDNA Factor V Leiden Genetic Health Risk Test Download Now Label Comprehension & Human Factors Studies AncestryDNA Saliva Collection Kit…
Home – Studies Refresh
…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…
What to Know About FDA’s Self-Selection Studies Guidance
…participant feedback. This user-centred approach to questionnaire design will help avoid incorrect responses due to bad questions versus genuine label comprehension issues. Consider having the FDA review your key label…
What We Do
What We Do We do social science iteratively and efficiently. Regulatory studies often require quality survey data collection. When human factors, label, self-selection, simulated use or user comprehension studies are…