Udemy - Human Factors and Usability Engineering in Medical Device...
- Category Other
- Type Tutorials
- Language English
- Total size 896.0 MB
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Infohash : 9C4D4FEC4019F4D8BA0A9B559696A35775F19310
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.
Files:
[ WebToolTip.com ] Udemy - Human Factors and Usability Engineering in Medical Devices- Get Bonus Downloads Here.url (0.2 KB) ~Get Your Files Here ! 1 - Introduction
- 1 -Introduction.mp4 (88.4 MB)
- 1 -149712019+A112021 Medical devices - Application of risk management to medical devices (ISO 149712019).url (0.1 KB)
- 1 -ANSIAAMI HE752009 (R2018) Human factors engineering - Design of medical devices.url (0.1 KB)
- 1 -Applying-Human-Factors-and-Usability-Engineering-to-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf (918.4 KB)
- 1 -Guidance-Human-Factors-Marketing.pdf (916.1 KB)
- 1 -Human Factors Process.mp4 (25.6 MB)
- 1 -IEC 62366-12015 Medical devices Part 1 Application of usability engineering to medical devices.url (0.1 KB)
- 1 -IMDRF_SaMD WG_Software-Specific Risk_N81 Final_0.pdf (597.6 KB)
- 1 -Premarket-Software-Functions-Guidance.pdf (1.2 MB)
- 2 -Define Intended Users, Device user interface, and Use Environments.mp4 (179.2 MB)
- 2 -Use Specification Template.docx (25.7 KB)
- 3 -Develop Use Scenarios.mp4 (48.0 MB)
- 4 -Conducting Task Analysis.mp4 (64.2 MB)
- 4 -Task_Analysis.docx (30.7 KB)
- 5 -Identify Use-Related Risks.mp4 (117.4 MB)
- 5 -User_Related_Risk_Analysis.docx (40.6 KB)
- 6 -Design User Interface (UI) with HFE Principles.mp4 (113.7 MB)
- 6 -User Interface (UI) Specification Template.docx (33.2 KB)
- 7 -Conduct Formative Usability Testing.mp4 (120.7 MB)
- 7 -Formative_Evaluation_Plan.docx (32.3 KB)
- 7 -Formative_Evaluation_Report.docx (50.5 KB)
- 8 -Conduct Summative Usability Testing.mp4 (89.4 MB)
- 8 -Summative_Evaluation_Plan.docx (36.7 KB)
- 8 -Summative_Evaluation_Report.docx (37.4 KB)
- 9 -Document HFE Activities for FDA Submission.mp4 (45.7 MB)
- 9 -Usability Engineering Report template.docx (26.1 KB)
- Bonus Resources.txt (0.1 KB)
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