Medical Human Factors
Medical Human Factors: Navigating through FDA’s Human Factors validation requirements without support can be a confusing, time consuming, and costly process for any medical company. Our goal is to simplify the FDA submission process into a manageable, easy to understand, and 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.
“This is my second occasion to provide feedback to a medical device manufacturer. I do appreciate the opportunity to share my expertise with the product developers. As physicians, we rely on their devices to help our patients, but sometimes the devices and/or the instructions are overly complicated. I think it’s great that they want to hear from clinicians when making design improvements.”