About this document
PMCF and PMS Risk Management Overview by Mohammed Hammed is a document available to read on EtoBox.
This document outlines the clinical evaluation report (CER) process for obtaining and maintaining a CE mark for medical devices. It includes: 1) Requirements for initial CER and ongoing updates whenever new information could impact the clinical evaluation or annually/every 2-5 years. 2) Details on post-market surveillance (PMS) including a PMS plan, collection and analysis of post-market data, and post-market clinical follow-up (PMCF) to continuously monitor device safety and performance. 3) Requireme
- Author
- Mohammed Hammed
- Language
- EN