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Ep.012 Safe and Effective Podcast: FDA Regulatory Roundup: CDER Human Factors ANDA Draft Guidance (ft. Melissa Lemke)
Podcast on FDA Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product in an ANDA.
Mar 42 min read
Breaking into Medical Human Factors: A Guide for Aspiring Human Factors Engineers
Breaking into Medical Human Factors: A Guide for Aspiring Human Factors Engineers
Feb 277 min read
The Critical Role of Human Factors Task Analysis in Medical Device Development: Bridging Human Factors and Risk Assessment
Task analysis in Human Factors Engineering ensures safe & effective MedDevices by mitigating errors and meeting FDA, IEC and MDR standards.
Jan 306 min read
Key Takeaways of FDA and CRCG 2024 DDCP Workshop: When Might "Other Design Differences" Be Justified Without a Comparative Use Human Factors Study (CUHF)?
Key Takeaways of FDA and CRCG 2024 DDCP Workshop: When Might "Other Design Differences" Be Justified Without a Comparative Use Human Factors
Jun 18, 20247 min read
HFUX Research Presenting at FDA CDER FY 2024 Generic Drug Science and Research Initiatives Public Workshop
It’s Hip to be Square: Demonstrating Equivalency without Inferiority in Comparative Use Human Factors Studies
May 3, 20242 min read
Determining When and How to Include Multiple Users in Human Factors Testing: Case Study Examples.
Examples of #UsabilityTesting for products in which multiple users may be involved in managing a #MedicalDevice for its #IntendedUse.
Apr 22, 20242 min read
Ep.008 Safe and Effective Podcast: Desperately Seeking: MedDev Human Factors Use Error Classification System (ft. Albert Boquet)
Podcast about using existing frameworks HFACS to develop a public use error classification system and database for human factors in MedDev.
Mar 22, 20242 min read
Ep.007 Safe and Effective Podcast: Women in (Med)Tech in HF/UX
Discussion on inequities / inequalities faced by women in the workplace, focusing on behavioral sciences, human factors and UX in (Med)Tech.
Jan 18, 20242 min read
Here's a Look Back at the 2023 HFES Aspire 67th International Annual Meeting
What a super awesome week the HFES 67th International Annual Meeting turned out to be.
Oct 31, 20232 min read
HFUX joins the The Medical Sales Accelerator Podcast
Heidi reveals the common areas where many innovators fall short & explores how human factors can enhance their efficiency in moving forward.
Oct 19, 20231 min read
We're Back - HFUX joins the Human Factors Cast and Show: This week 'Road Rage Meets Robo-Cars'
Episode 282: On this episode the human factors cast discover how road rage affects your #driving and the potential impact on #selfdriving...
May 17, 20231 min read
Announcing: Safe and Effective | The Medical Human Factors Podcast!
This is the official trailer for Safe and Effective, the Medical Human Factors Podcast.
Mar 25, 20231 min read
On a Roll - HFUX joins the Human Factors Cast and Show: This week 'How the Culture Affects HCI'
Episode 272: On this episode the human factors cast talked about #culture, #cognition, and #humancomputerinteraction. They also answer...
Feb 23, 20231 min read
Back at it again - HFUX joins the Human Factors Cast and Show: This week 'Pilots in Distress'
Episode 266: On this episode the human factors cast talked about the system that keeps #pilots from seeking #mental #healthcare. They...
Dec 7, 20221 min read
HFUX again joins the Human Factors Cast and Show: This week discussing 'Talking to Dead People'
Episode 263: On this episode the human factors cast talked about technology that lets us “speak” to our dead relatives via AI and whether...
Nov 4, 20221 min read
HFUX joins the Human Factors Cast (Podcast) discussing 'Robotic Boots are Walking the Walk'
Episode 262: On this episode the human factors cast talked about how the Stanford exoskeleton walks out into the real world. They also...
Oct 28, 20221 min read
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