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204 results
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Brazil Regulatory Updates

Watch as our regulatory experts discuss Brazil’s evolving medical device regulatory landscape, covering developments...
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Open Forum: Usability Testing Q&A

Our senior HFE experts will answer your pre-submitted and live questions on conducting usability testing of medical...
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Emergo by UL HFR&D Team Highlights from the 2025 HFES Health Care Symposium

Hear the latest on scoping human factors engineering (HFE) work to support global market access, designing custom AI...
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U.S. FDA Clinical Data Requirements for Medical Devices

Learn more about when clinical data is required for U.S. Food and Drug Administration (FDA) submissions such as 510(k),...
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EU AIA and its Interplay with the EU MDR/IVDR

Know how the EU Artificial Intelligence Act redefines the regulatory environment for AI-driven medical devices and IVDs.
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Insights and expertise gained from a year of applying the 2024 HF guidance

Gain a deeper understanding of how to interpret and meet NMPA’s HF expectations.
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Understanding Japan’s Clinical Data Requirements

The PMDA determines if clinical data is required for a medical device premarket authorization in Japan depending on the...
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Determining when to Utilize the Pre-Submissions Q-Submission (Pre-Sub) Process

Optimize your FDA Pre-Sub process and know when to use the Pre-Sub option for better regulatory outcomes.
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U.S. FDA Medical Device Testing for Premarket Submissions

Gain insights into U.S. FDA regulatory classifications and testing requirements for introducing medical devices to the...
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Open Q&A forum: Maximizing Human Factors in Early Product Development

Our senior human factors engineering (HFE) and design experts answer questions about how to strategically approach...
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U.S. FDA Medical Device Predicate Selection for 510(k) Submissions

Learn more about the strategies for tackling challenges and boosting submission success for FDA 510(k) predicate...
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Overview of the IVD regulatory landscape in Brazil

Learn more about the IVD regulatory landscape in Brazil.
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