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Europe In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process
In order to commercialize in vitro diagnostic (IVD) devices in the European Union , a CE Mark certificate is needed. This certification verifies that
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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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Register for our webinar: Post Market Surveillance & PMCF under the European MDR
PMS & PMCF under the European MDR
Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) adds to the
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Learn about the European Directives and Regulations which apply to medical devices
Medical Device Regulations in Europe
All regulatory documents shown below were published by the European Parliament or European Commission. Please help us maintain this list by reporting
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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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Introduction to European CE Marking for medical devices
Europe is the world's second-largest medical device market with 500 million people, 20+ languages, 32 countries and (fortunately) only one approval
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Regulations for Companion Diagnostics in the US and EU
Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision
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Watch our recent webinar on the European In Vitro Diagnostic Devices Regulation
WATCH NOW: Europe's New IVDR 2017/746
Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The current In Vitro Diagnostic
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