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Combination products use errors white paper
Combination products: common use errors and design considerations
Combination products, such as injection devices, inhalers, nebulizers, and drug patches, are increasingly being used by laypeople for self-
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Combination products home injections
Latest FDA Expectations for Conducting Human Factors Validation Tests of Combination Products
FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents.
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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The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come
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Medical device monitor
The Role of Hardware User Interface Design in Medical Devices
Designers from Emergo by UL’s Human Factors Research & Design (HFR&D) team share tips and insights about the importance of hardware user
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Meeting FDA expectations for human factors engineering activities
Meeting FDA expectations for human factors engineering activities
Meeting FDA expectations for human factors engineering activities FDA has provided industry with guidance on how to apply human factors engineering (
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Medical Device Regulatory Market Access in Times of a National Emergency
Hosted by the University of Illinois, this special webinar was developed to explain what non-medical manufacturers need to know to help alleviate
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Residual risk analysis white paper
Residual risk analysis of user interaction problems
Residual risk analysis is a process whereby medical device and IVD manufacturers can integrate observed use errors into their design considerations
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