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EU MDR & IVDR Updates

Dec 04, 2023

Which EU Notified Bodies Are Designated Under the MDR 2017/745 and IVDR 2017/746?

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Sep 19, 2023

Regulatory Requirements for EU MDR Annex XVI Devices: What You Need to Know

Aug 07, 2023

How Indications for Use Impact Medical Device Classification

Jul 23, 2023

Understanding FDA and EU Medical Device Labeling Requirements

Feb 21, 2023

Europe’s New Plan to Relieve the EU MDR Traffic Jam

Post Market Surveillance Reports

Feb 13, 2023

An Overview of Medical Device Periodic Safety Update Reports (PSUR) and Postmarket Surveillance Reports (PMSR) Under the EU MDR