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Extended MDR Date of Application: Optimizing your PMS and clinical activities
Now that the European Medical Devices Regulation (MDR) final date of application has been pushed to May 2021, medical device manufacturers should
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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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Brazil registration webinar 2018
WATCH NOW: Brazil ANVISA Medical Device Registration
Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a
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WATCH NOW: Overview of the MDSAP Certification Process
WATCH NOW: Overview of the MDSAP Certification Process
The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device
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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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Medical device registration in China webinar
NMPA medical device registration requirements in China
China represents a vast market for medical devices, but its regulatory system can be difficult to navigate. A recent report published by China’s
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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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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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Register for our free webinar on choosing or changing your EU Notified Body
WATCH NOW: How to Select or Change Your EU Notified Body
European Notified Bodies are under intense scrutiny by Competent Authorities, and that oversight has filtered down to their clients. A few years ago
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