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Science / Medical technology / Information science / Pharmaceutical industry / Quality / Validation / Medical device / Conformity assessment / Documentation / Medicine / Technology / Medical equipment


Technical Reference: TR-002 Date of Issue: 13 Oct[removed]Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
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Document Date: 2013-05-09 00:43:18


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File Size: 198,51 KB

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IndustryTerm

higher risk class devices / diagnostic devices / applicable device / similar marketed devices / local manufacturers / similar devices / low risk devices / manufacturing processes / subject medical device / software validation / /

Position

General / Validation Documents General / Demonstrate Conformity General / /

PublishedMedium

Conformity / /

Technology

Design Verification / /

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