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state of the art

Mar 22, 2022

State of the Art in the EU MDR: What Does That Actually Mean?

Oct 12, 2021

eLabeling and eIFU Requirements Under the EU MDR and Regulation 2021/2226

Risk Benefit

Jun 02, 2021

You’ve Evaluated Every Risk But Are You Properly Documenting Medical Device Benefits?

EU MDR (2017/745) Update

Apr 01, 2021

Latest EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Updates

Apr 22, 2020

The EU MDR Has Been Pushed Out to 2021. That’s a Golden Opportunity

Apr 15, 2020

2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations