Navigating through FDA’s Human Factors validation requirements without support can be a confusing, time consuming, and costly process. Our goal is to simplify the FDA submission process and provide you with a clear path from start to finish. Our Human Factors researchers have successfully overseen dozens of research programs aimed at getting medical devices approved through FDA. Through this experience, we understand the types of challenges, questions, and pitfalls that exist throughout this process. We also know that no two products – or companies – are alike; each program needs to be tailored to fulfill the demands of internal and external clients, R&D capabilities, company budgets, and deadlines.
Human Factors Planning
Our team will work with you to ensure your project plan incorporates human factors activities following FDA and EU regulations.
A robust task analysis provides the foundation for a sound human factors strategy. We work with you to identify all the tasks required for successful device use, and define task criticality.
Known Issues Review
We perform in-depth reviews of various databases to identify known use-related issues with devices like yours helping you save time by avoiding those same use errors.
We perform research with your users in their natural environments to help you design products that meet their needs and improve safety and efficacy.
Smaller-scale formative evaluations that are designed to find potential use errors are essential to designing a device that passes validation testing on the first attempt.
The validation study should be the capstone to a human-centered design process. We design validation studies to uncover any residual use errors, and provide a detailed root cause analysis.