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White paper: how to conduct a medical device PMCF study
White paper: How to conduct medical device PMCF studies
The EU Medical Devices Regulation (MDR (EU) 2017/745) places greater emphasis on Post-Market Clinical Follow-up (PMCF) studies. Manufacturers are
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Clinical Investigational Studies in Europe
Many medical device companies think they are ready to conduct clinical investigation studies when they are actually months--if not years--away from
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How to Select and Change a Notified Body in Europe
Selecting a Notified Body (NB) is an important (and required) step for obtaining CE Marking and registering your medical device for sale in the
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Unannounced Notified Body Audits & Your Critical Suppliers
Many medical device manufacturers don't realize that Notified Bodies can perform unannounced audits of your quality system. They can even audit your
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Medical Device Clinical Evaluation Reports for European CE Marking
Are you thinking of marketing your medical device in Europe? If so, you must write and maintain a clinical evaluation report (CER) as part of your
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Introduction to CE Marking for Medical Devices
Are you a medical device manufacturer with your eye on the European market? If so, you've probably heard the term "CE Mark". The CE Mark is the key
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ISO 10993-1 and Biocompatibility for Medical Devices
Biocompatibility testing: an intimidating, time-consuming, and, at times, very expensive requirement in most major medical device markets.
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Post-Market Clinical Follow-up (PMCF) studies under the EU MDR
Post-market Clinical Follow-up (PMCF) is an important part of ongoing medical device regulatory compliance in the EU. PMCF can sometimes require you
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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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