Mar 07, 2022

Preparing for a Notified Body Medical Device Clinical Audit

Chart-investigation-flow-diagram

Mar 25, 2021

How Much Postmarket Surveillance (PMS) Data Should We Have In Our Clinical Evaluation Reports (CERs)?

Dec 22, 2020

EU MDR CER and EU IVDR PER for Software:
Understanding MDCG 2020-1

Jun 25, 2020

MDCG 2020-5 Gives Unequivocal Guidance on Medical Device Equivalence Under the EU MDR

Jun 09, 2020

Understanding EU MDR Clinical Evidence Required for “Legacy” Medical Devices as Outlined in MDCG 2020-6