…STUDY Genetic Health Risk Test LABEL COMPREHENSION STUDY EU Medical Device Granted US FDA Clearance. USER COMPREHENSION STUDY & ACTUAL USE STUDY Genetic Health Risk Test & Saliva Collection Kit…
Results for "user comprehension"
Ancestry closes DNA Health Business only months after obtaining FDA DTC Approval (K192944) with SoundRocket help
…the test report while also designing and implementing a user comprehension study which demonstrated the illusive 90% comprehension in key areas (i.e.: domains) such as test results, test purpose, test…
Co-Pilot
…user understanding and interpret product labeling information. Asses user understanding and retention of key information from provided materials. Determine if users can correctly decide if a product is appropriate for…
Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension
…is also important to have diverse groups of people participate in non-clinical user research. This includes label comprehension, user comprehension, simulated use, self-selection, and other human factors studies. These studies…
FDA Guidance on Human Factors and Usability Engineering for Medical Devices
…consider the medical device’s intended users, use environments, and user interfaces. For example, intended users might be patients, caregivers, and/or medical professionals. Considering how each group brings different knowledge and…
Direct-to-Consumer Polygenic Risk Scores Move Towards FDA Regulation
…in the GHR regulation, which is likely to be part of the polygenic risk score protocol as well, is a user comprehension study designed to show that naive users can…
From Academia to the FDA: How SoundRocket Launched into Regulatory Research
…journey took an unexpected turn. Today, SoundRocket is a trusted partner in regulatory research, helping companies navigate the complexities of FDA submissions through user comprehension, label comprehension, self-selection, simulated use,…
CRO Partnerships
…meet FDA standards. User Comprehension Studies Evaluating if users can understand and appropriately act on genetic health risk reports. Self-Selection Studies Assessing whether consumers can make informed product choices based…
Insights on the FDA’s Virtual Public Meeting: Home as a Health Care Hub Initiative
…Home as a Health Care Hub Initiative To truly make the Home as a Health Care Hub initiative successful, it’s crucial that the FDA considers making user comprehension, label comprehension,…
How We Do It
…qualitative research methods (cognitive interview, focus groups, etc.), data collection (all modes and methods), and data reporting for your next research endeavor. Human factors studies like user comprehension studies, label…