Download Team NB PositionPaper BPG TechnicalDocEU MDR 2017 745 V1 20221005 PDF Free - Full Version
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About Team NB PositionPaper BPG TechnicalDocEU MDR 2017 745 V1 20221005
This document provides guidance from Team NB, an association of European notified bodies, on submitting technical documentation for medical devices to notified bodies under the Medical Device Regulation. It outlines general considerations and specific content that should be included for device description, design and manufacturing information, safety and performance requirements, verification and validation, and other areas. The goal is to provide a collaborative approach and unified expectations for technical documentation submissions to avoid delays in review from notified bodies.
Detailed Information
| Author: | ['eli'] |
|---|---|
| Publication Year: | 2022 |
| Pages: | 44 |
| Language: | English |
| Format: | |
| Price: | FREE |
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