Human Factors Engineering
RDEC integrates Human Factors Engineering (HFE) into the medical device development process to enhance usability, minimize use-related risks, and ensure regulatory compliance. By focusing on user-centered design principles, we help clients develop intuitive, safe, and effective medical devices that improve patient outcomes and streamline healthcare workflows.
- User Needs & Use Environment Analysis
Understanding the needs, behaviors, and limitations of end-users (patients, caregivers, and healthcare professionals) to design devices that optimize usability and safety. - Use-Related Risk Analysis & Mitigation
Identifying potential use errors, assessing associated risks, and developing strategies to mitigate user-related hazards in compliance with ISO 14971. - Task Analysis & Workflow Evaluation
Evaluating how users interact with medical devices in real-world settings to improve safety, efficiency, and ease of use. - Formative Usability Testing
Early-stage usability testing to gather user feedback and refine device design before formal validation studies. - Summative Usability Testing
Leading FDA-compliant usability studies to demonstrate that devices can be used safely and effectively by the intended users in real-world conditions. - Regulatory Compliance Support
Preparing Human Factors Engineering reports and documentation for FDA and other regulatory submissions, ensuring compliance with usability standards.