About this document
EU Post-Market Surveillance Compliance by vadi is a document available to read on EtoBox.
The document outlines the EU Post-Market Surveillance (PMS) requirements for medical devices, detailing the obligations of manufacturers under various directives and standards. It emphasizes the importance of systematic procedures for monitoring device performance and reporting incidents to competent authorities. Additionally, it discusses common compliance issues observed during audits and the necessity for proactive and reactive PMS strategies.
- Author
- vadi
- Language
- EN