Service Description

Medical device usability plays a critical role in patient safety, regulatory approval, and market success. Poor usability can lead to user errors, device misuse, and regulatory rejections, increasing risks for both patients and manufacturers. This course provides a comprehensive, step-by-step guide to Human Factors and Usability Engineering (HFE/UE), ensuring compliance with US FDA, EU MDR, IEC 62366-1, and ISO 14971. You will learn how to apply usability engineering principles to medical device design, conduct formative and summative usability testing, and integrate Human Factors into risk management. The course covers regulatory expectations, risk-based usability design, user interface (UI) design best practices, and usability documentation for regulatory submissions. Whether you’re a medical device engineer, regulatory professional, UX designer, or clinician, this course will equip you with the skills and tools to optimize device usability, reduce user errors, and ensure FDA, EU MDR compliance. What You Will Learn:Apply Human Factors Engineering (HFE) principles in medical device development Applying Human Factors Engineering (HFE) Principles in AI and Software as a Medical Device (SaMD)Ensure compliance with US FDA, EU MDR, IEC 62366-1, and ISO 14971 usability requirementsConduct task analysis, usability risk assessments, and usability testingDesign intuitive, safe, and user-friendly medical devicesPrepare Human Factors documentation for regulatory submissions Enroll now and take your medical device usability expertise to the next level!