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Understanding the EU IVDR white paper by Emergo by UL
Applying Human Factors Engineering (HFE) to in vitro diagnostic (IVD) products under the European IVD Regulation (IVDR)
Yvonne Limpens and Brenda van Geel from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the upcoming
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The EU MDR and human factors engineering (HFE) requirements for post-market surveillance (PMS)
The EU Medical Devices Regulation (MDR) includes specific requirements for post-market surveillance (PMS), calling on medical device manufacturers to
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Illustration of a calendar with one date circled
Clinical Evaluation Reports (CER) for Medical Devices
The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR). This scrutiny leaves
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Two human factors researchers wearing surgical masks observe a human factors study of a medical device occurring in an observation room.
Conducting Safe In-person Testing During COVID-19
The experts from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights learned from creating a safe setting to
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MDR and Human Factors – get ready for transition
The transition period from MDD to MDR comes to an end on May 26th, 2021. Among the many regulatory changes, the role of human factors is greatly
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MDR and Combination Products
Combination products, usability, and the EU MDR
The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come
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Illustration of an imaging medical device
Applying Human Factors and Usability Engineering to Medical Devices (GERMAN) - Part I
This webinar is in German. This is the first session of a two-part webinar series; watch Part II below. Emergo by UL offers a wide range of services
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NMPA Expectations for Applying Human Factors Engineering (HFE) to Medical Devices
Yvonne Limpens and Ryan Zhang from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the NMPA’s HFE
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Nurse aligning a patient in order to take an x-ray
Conducting Usability Tests in China for NMPA: An Overview of Considerations Based on Past Learnings
Learn how the NMPA’s HFE guidelines impact HFE work and the best ways to plan and conduct usability tests in China for NMPA.
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