[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 […]
[FEATURED] Where And How eIFU Rules Will Apply Under The EU’s Medical Device Regulation
Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation. […]