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Clinical data and post-market compliance under the MDR
Clinical data and post-market compliance under the MDR
Europe's new Medical Devices Regulation (MDR) emphasizes a life-cycle approach to medical device risk management. To support this approach, the MDR
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Practical implications of the new EU MDR and ISO 14971 on post-market surveillance
The Final Draft International Standard (FDIS) of the 3rd Edition of ISO 14971 is now in its final stages and is expected to be published in August of
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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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CER Complience webinar EMERGO 2018
WATCH NOW: Ensure Your CER Complies with MEDDEV 2.7/1 v4
Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and
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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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Watch our recent webinar on Medical Device Approval in Japan
WATCH NOW: Japan's Medical Device Approval Process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your
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WATCH NOW: Medical Device Registration in Mexico
Mexico is one of the largest medical device importers in the world, making it an attractive market for foreign companies. The Federal Commission for
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KSA webinar January 2019
WATCH NOW: Medical Device Registration Requirements in Saudi Arabia
Recorded on January 22, 2019 The Kingdom of Saudi Arabia (KSA) is the largest market in the GCC region and relies on international imports for
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Register for our webinar: South Korea Medical Device Registration
Medical device and IVD registration in South Korea
South Korea is one of the most promising medical device markets in Asia. The Ministry of Food and Drug Safety (MFDS) regulatory process is well
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