…510(k)? In a 510(k) for DTCGTs, the FDA will evaluate several criteria, including analytical validity (i.e.: accuracy and reliability of your genetic test), clinical validity (i.e.: your test’s ability to…
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Research Wonder: DNA with a bow on it, a gift that may (unexpectedly) ‘keep on giving’
…by companies like 23andMe and Ancestry.com) are available for quick and easy purchase online, usually at a seasonal sale price. Gift recipients can send their DNA for analysis…
Research Wonder: Weather conditions looming? Now, tell me about your social anxiety
…and often control for, in our studies. In a recent study completed in France, Guéguen and Jacob found that on sunny days, respondents cooperated with a survey request coming from…
Navigating the Evolving Landscape: Risk Analysis and Human Factors in AI-Enabled Medical Devices
…emphasizes comprehensive HFE risk assessments and usability studies in its recent guidance for AI-enabled devices. Leveraging Existing Frameworks and AI for Risk Management The principles of ongoing monitoring, common in…
How Patient Preferences Shape Medical Device Development: Insights from FDA Draft Guidance
…to help medical device manufacturers and drug companies navigate the evolving landscape of patient preference research. Here’s how we can support you: Regulatory-Focused Research Consulting: We offer expertise in research…
Our expertise
…quality at every step. Study design Crafting the blueprint for your research. Study design is a critical and complex step in social science research. SoundRocket guides decisions on design type,…
Survey Sciences Group, LLC: Our Story – Part 2
…research, where there also exists an insane desire to reinvent the wheel for each study. As a result, academic research is often needlessly cumbersome, inefficient, and wasteful of resources. Our commercial…
Understanding LDTs with Real-World Examples
…in advancing healthcare: 1. Genetic Screening and Testing LDTs shine in cases where no FDA-approved test exists. Most clinical genetics tests are LDTs. Here are some common examples: Diagnostic testing…
Social Science Research: Are We Truly Innovating?
… or are social scientists just building a better rope? When I think of innovation in social science research, I think of innovation in our “sister” field of land surveying….
A Governmental “Source of Public Randomness”
…have the same flaw. Since then I have come to value true randomness. Do I need it in my day-to-day life? Not really – yet. Excel or SPSS are usually…