About this document
Best Practice for IVD Technical Docs by Adriana Voiculet is a document available to read on EtoBox.
This document provides guidance for manufacturers on submitting technical documentation to notified bodies for conformity assessment of in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. It outlines the key information to include regarding device description, design and manufacturing, performance evaluation, and post-market surveillance. The goal is to establish a unified approach and avoid delays due to incomplete or disorganized submissions. Manufac
- Author
- Adriana Voiculet
- Language
- EN