MDCG Q&A on Vigilance Terms and Concepts: Overview
The article provides a general overview of the EU vigilance regulatory framework.
The article provides a general overview of the EU vigilance regulatory framework.
The article provides a general overview of the regulatory approach to be applied with respect to corrective actions.
The new article further elaborates on the most crucial aspects related to corrective and preventative actions to be taken by the parties responsible for medical devices in order to ensure continued safety and proper performance.
The new article pays special attention to the role of the key parties involved.
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
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