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工業技術研究院

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技術名稱: 法規資源系統

技術簡介

通過資訊管理系統管控醫療器材設計管制流程,以符合法規在品質管理系統及上市前認證之要求

Abstract

A web-based information management system to support users to control their medical device design control process, so as to better utilize regulatory resource to fulfil regulatory requirement in quality management and pre-market submission.

技術規格

‧ ISO 13485與FDA QSR之設計管制 ‧ ISO 14971 風險管理 ‧ IEC 62366 人因/可用性工程 ‧ 製程確效 ‧ 文件管理 ‧ 版本控制 ‧ Technology Readiness Levels (TRL) ‧ FDA 21 CFR Part 11

Technical Specification

‧ISO 13485 and FDA QSR based design control ‧ISO 14971 based risk management ‧IEC 62366 based human factor/usability engineering ‧Process validation ‧Document management ‧Revision control ‧Technology Readiness Levels (TRL) ‧FDA 21 CFR Part 11

技術特色

我國第一套以法規要求為本之醫療器材設計管理系統

應用範圍

醫療器材之設計管制

接受技術者具備基礎建議(設備)

web伺服器與資料庫伺服器 ‧ CPU: 四核心(每核心運算能力2.0GHz以上) ‧ RAM: 8G以上 ‧ Storage: 500G以上 (視資料量而定) ‧ Win server 2008R2 版本以上 ‧ SQL Server 2008R2版本以上 建議使用IE 8以上瀏覽器或Google Chrome

接受技術者具備基礎建議(專業)

1.基本醫療器材法規了解 2.醫療器材品質系統 3.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:廖盛惠 量測技術發展中心

電話:+886-3-5732294 或 Email:sliao@itri.org.tw

客服專線:+886-800-45-8899

傳真:none

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