Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

How ISO 13485:2016 Impacts Medical Device Companies
The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how
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Understanding Europe's New IVDR 2017/746
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring
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Download the Chart on the Medical Device Approval Process in Europe
Europe CE Marking Regulatory Process for Medical Devices
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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Download the Chart on the IVD Approval Process in Europe
European IVD Regulatory Approval Process
IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a
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Understanding Europe's New Medical Device Regulation - MDR 2017/745
You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What
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This chart illustrates CE Marking for medical devices under Europe's MDR.
Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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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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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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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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