Resources

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

LOG INTO RAMS

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-
Read More
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.
Read More
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
Read More
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
Read More
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
Read More
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The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come
Read More
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
Read More
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
Read More
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
Read More