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Ep.012 S&E Podcast: FDA Regulatory Roundup: CDER Human Factors ANDA 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
74 views
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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
288 views
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
136 views
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'Safe and Effective' Joins the 'Beers with Engineers' Podcast
Podcast about Engineering with Engineers; in this episode: Human Factors Engineering in Medical Device Development.
Jul 21, 20242 min read
44 views
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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
138 views
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Ep.009 S&E Podcast: AI in Healthcare Human Factors: Ready or Not, Here it Comes, Can We Hide? (ft. Kate Preston and Barry Kirby)
Podcast about developing and using AI in healthcare and medical device and technology development and its human factors challenges.
Jun 7, 20242 min read
56 views
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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
70 views
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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
183 views
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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
23 views
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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
25 views
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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
38 views
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Ep.002 Safe and Effective Podcast: Human Factors in MedDev Design & Engineering (ft. Maggie Reiff)
Safe and Effective, The Medical Human Factors Podcast. Latest developments in medical human factors and UX, including regulatory.
Jul 18, 20231 min read
54 views
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HFUX Research will be exhibiting at MD&M East in New York City from June 13 to 15, 2023!
The #HFUXResearch team is pleased to announce that we’ll be exhibiting at MD&M East in New York, New York at the Jacob Javitz Convention...
May 30, 20231 min read
27 views
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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
42 views
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