Resources

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

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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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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CE Marking Conformity Assessment for Medical Devices
Ready to sell your medical devices in Europe? First, you must comply with Europe’s medical device regulations. But instead of a one-size-fits-all
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Conducting a medical device PMCF webinar
WATCH NOW: 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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ISO 13485:2016 and the new Risk-based Approach
The new ISO 13485:2016 quality management system standard for medical devices introduces lots of new changes and concepts. However, its emphasis on
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Introduction to Clinical Evaluation Reports (CER) for Europe
Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device,
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