Udemy - Human Factors and Usability Engineering in Medical Devices

Human Factors and Usability Engineering in Medical Devices

https://WebToolTip.com

Published 2/2025
Created by eQMS Innovation
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Level: Beginner | Genre: eLearning | Language: English | Duration: 10 Lectures ( 1h 48m ) | Size: 896 MB

Ensuring FDA Compliance and User-Centered Design

What you'll learn
Understand FDA & Global Regulatory Requirements
Learn how FDA, IEC 62366-1, ISO 14971, regulate Human Factors Engineering and usability testing in medical device development.
Integrate Human Factors into Risk Management
Identifying use-related hazards, critical tasks, and risk control measures
Develop and Execute Usability Testing Plans
Apply human-centered design principles to create medical device interfaces
Prepare FDA-Compliant Usability Documentation

Requirements
Basic Understanding of Medical Devices and Regulations – Familiarity with medical device development, FDA, EU MDR, or ISO 13485 is helpful but not required. The course will introduce key regulatory aspects of Human Factors and Usability Engineering.
Interest in Risk Management and Usability – A general understanding of risk management concepts (ISO 14971) and how medical devices interact with users can enhance learning but is not mandatory.
No Special Software or Tools Required – Learners only need a computer with internet access. Templates and guidance on usability testing tools (e.g., usability studies, and task analysis, formative and summative evaluations) will be provided.
Open to All Professionals – Ideal for engineers, regulatory specialists, quality assurance professionals, UX/UI designers, and healthcare professionals involved in medical device development.