Resources

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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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Marketing medical devices in the post-Brexit era: Working with a UK Responsible Person (UKRP)
The UK's withdrawal from the European Union has major ramifications for medical device manufacturers, including in-country representation
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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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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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MDR and Combination Products
Combination products, usability, and the EU MDR
The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come
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14971 risk management webinar
WATCH NOW: Risk Management according to EN ISO 14971:2012
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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