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工業技術研究院

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技術名稱: OMDE醫療器材審查案件管理系統

技術簡介

透過線上案件管理系統,可執行案件審查進度管理、控制及數據分析、報告,提升醫療器材法規審查品質及效率。

Abstract

A web-based information management system to that build to manage, control regulatory submission, and to report analysis result, if necessary, in order to increase the quality and effeciency of medical device regulatory review.

技術規格

Microsoft .net 資訊管理系統

Technical Specification

Microsoft .net based database and information system

技術特色

可處理大量案件之進度控管,為我國第一套醫療器材法規審查案件管理系統

應用範圍

醫療器材之510(k)、GMP/QSD、查驗登記、ISO 13485驗證

接受技術者具備基礎建議(設備)

一般可上網電腦系統,適用於一般電腦、平板、手機等硬體,軟體上支援windows 7, windows 8, android, MAC等。

接受技術者具備基礎建議(專業)

1. 醫療器材審查員 2. 醫療器材相關法規 3. 醫療器材品質系統 4. 產品標準

技術分類 生技醫療與綠色能源- 認證/驗證技術

聯絡資訊

聯絡人:吳俊彥 量測技術發展中心

電話:03-5732043 或 Email:jywu6@itri.org.tw

客服專線:+886-800-45-8899

傳真:none

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