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MDR PMS and PSUR requirements white paper
PMS & PSUR requirements under the EU MDR
Medical device post-market surveillance (PMS) activities have already been described in the European Medical Device Directive (93/42/EEC) and are
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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: 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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MDR and Human Factors – get ready for transition
The three-year transition period from MDD to MDR comes to an end on May 26th 2020. Among the many regulatory changes, the role of human factors is
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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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EU MDR Readiness Checklist
EU MDR Readiness Assessment Checklist
How prepared is your company for compliance to the European Medical Devices Regulation (MDR)? Medical device CE Marking requirements will change
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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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Conducting a medical device PMCF webinar
Conducting a Medical Device PMCF Study
The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting structured post-market data
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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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