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Two people reviewing documents in a lab
Clinical data and post-market compliance under the MDR
Gain insights from Emergo’s medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF
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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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Illustration of a calendar with one date circled
Clinical Evaluation Reports (CER) for Medical Devices
The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR). This scrutiny leaves
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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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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
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Register: Eudamed Webinar July 2018
WATCH NOW: Eudamed Requirements under the EU MDR and IVDR
As it prepares to meet new regulatory requirements in Europe, the medical device community is also following developments about the European Database
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EU mdr delay
MDR Transition: Countdown to compliance
When the European Medical Devices Regulation 2017/745 (MDR) takes effect, it will transform the regulatory system that governs the world’s second-
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