Human factors studies and usability engineering are critical elements in the safe, effective, and user-centered design of medical devices. These disciplines ensure that devices are intuitive, reduce the likelihood of use errors, and support positive patient outcomes....
FDA-compliant label comprehension studies are a critical part of the U.S. Food and Drug Administration (FDA) clearance process for over-the-counter (OTC) drugs and medical devices. These studies help ensure that consumers can safely and effectively use nonprescription...
FDA Risk Analysis, including Use-Related Risk Analysis (URRA), is no longer optional—it’s essential for medical device compliance. This guide explains URRA, why it’s vital for FDA submissions, and how to initiate effective risk management early in device development....
Ann Arbor, MI – February 21, 2025 – SoundRocket, a leader in user comprehension research for regulated medical and diagnostic devices, is proud to announce its role in securing FDA clearance for the GlutenID Celiac Genetic Health Risk (GHR) Test (K241456), developed...
A Data-Driven Campus Starts with the Right Questions A university campus is more than just classrooms and dorms—it’s a living, breathing community. But how do you truly understand what students, staff, and faculty are experiencing? At SoundRocket, we believe that the...
Our Rocket’s Unexpected Trajectory When we founded SoundRocket (then known as Survey Sciences Group, LLC) in 2004, we had no idea we’d one day be playing a critical role in regulatory health communications research. Our roots were firmly planted in academic social...
Introduction Questionnaire design is a cornerstone of survey research. It guides the development of questions, structures the survey, and ensures it achieves the intended research objectives. Strong design enhances the validity and reliability of the data collected in...
Navigating FDA regulatory compliance for medical devices is a multifaceted challenge that demands precision, expertise, and seamless collaboration. For medical device regulatory consultants and compliance-focused professionals, partnering with a specialized Contract...
Introducing a Specialized CRO for FDA 510(k) Study Needs Bringing a medical device to market requires navigating complex FDA regulatory pathways for medical devices. These pathways—such as premarket notification (510(k)), premarket approval (PMA), and De Novo...