[Ask the Expert] Common Notified Body Review Findings
This session’s topic: Tips For How to Avoid Common Notified Body Review Findings Criterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions […]
“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits
Author: Stacie Beecham Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, […]
Expert Opinion Panels and New Guidance Documents Are Part of the Changing Landscape of MDR 2017/745
Author: Suzanne Broussard, PhD | February 25, 2022 The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights […]
