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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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Preparing a European CE Technical File for a Medical Device
Want to sell your medical device in Europe? If the answer is yes, you probably have a lot of questions about one of the key elements of the European
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Implementing a Medical Device Post-Market Surveillance Program
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system
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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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ITALY – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and healthcare market data on Italy, plus specific information about the medical device and healthcare
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IGJ - The Dutch Health and Youth Care Inspectorate
The Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd or IGJ) is the Dutch government agency within the Ministry of Health,
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EU Medical Device Vigilance Reporting
Medical device manufacturers selling in Europe are legally obligated to report adverse events, incidents, and recalls, also known as vigilance
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CER Complience webinar EMERGO 2018
WATCH NOW: Ensure Your CER Complies with MEDDEV 2.7/1 v4
Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and
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Netherlands – Overview of medical device industry and healthcare stats
Below you will find basic demographic and economic data for The Netherlands, plus specific information about the country's medical device and
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