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Illustration of a calendar with one date circled
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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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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How device companies can prepare for a no-deal Brexit
Impact of a No-Deal Brexit
Emergo’s regulatory experts in Europe are closely monitoring developments in British Parliament to assess how potential Brexit outcomes could affect
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Emergo MDR webinar October 2017
WATCH NOW: The new European Medical Devices Regulation (MDR 2017/745)
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect for a
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Register for our free webinar on Transitioning to ISO 13485:2016
WATCH NOW - What You Need To Know about ISO 13485:2016
ISO 13485:2016 is the first major revision to the global quality system standard since 2003. In this one hour recorded webinar we cover the major
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