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Which EU Notified Bodies Are Designated Under the MDR 2017/745 and IVDR 2017/746?
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Regulatory Requirements for EU MDR Annex XVI Devices: What You Need to Know
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How Indications for Use Impact Medical Device Classification
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Understanding FDA and EU Medical Device Labeling Requirements
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Europe’s New Plan to Relieve the EU MDR Traffic Jam
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An Overview of Medical Device Periodic Safety Update Reports (PSUR) and Postmarket Surveillance Reports (PMSR) Under the EU MDR