Resources

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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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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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Brazil's medical device regulatory update
In recent years, ANVISA released numerous regulatory updates to make Brazil a more accessible medical device market. Currently, the medical device
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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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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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Preparing for the EU MDR Date of Application
The EU Medical Devices Regulation (MDR) Date of Application (DoA) is imminent. Do you understand what your regulatory obligations will be as of May
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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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