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.