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Technical Dossier for Non-Active Devices by RoxanaBurla is a document available to read on EtoBox.

What is Technical Dossier for Non-Active Devices about?

This document provides guidance on compiling technical files and design dossiers for non-active medical devices. It outlines a 12 section structure including an introduction, essential requirements checklist, risk analysis, drawings and specifications, testing requirements, clinical data, packaging and labeling. The risk analysis section describes applying ISO 14971 to identify hazards and failure modes, analyzing risks, and implementing and verifying risk reduction measures. Technical files are retained by

Author

RoxanaBurla

Language

EN