…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…
Results for "user comprehension"
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…
About Us
…problems. Schedule a meeting with Scott Provides strategic support for health-related comprehension studies, including those required for regulatory compliance, such as FDA user comprehension, label comprehension, self-selection, and consumer user…
FDA Human Factors Studies
…analysis and detailed reports meeting FDA standards for clear, actionable results. USER COMPREHENSION STUDY Genetic Health Risk Test LABEL COMPREHENSION STUDY EU Medical Device Granted US FDA Clearance. USER COMPREHENSION…
The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 2)
…pros with your FDA user comprehension study. Turn to survey experts (like us) who are familiar with user or label comprehension studies for regulatory purposes, as we know what the…
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,…
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…
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,…
Home
…social science research, and custom survey services to meet your research needs. Diversity, Equity and Inclusion (DEI), Sexual Misconduct, Substance Use User Experience, User Comprehension, Label Comprehension, FDA and Regulatory…
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…