歐盟醫療器材軟體之實務認證-以12-lead ECG 暨遠距醫學資訊整合系統為例

The Practice of Medical Software Verification and Validation for EU Certification - An Example of the 12-Lead ECG Telemedicine Information System

林怡君(Yi-Chun Lin)

指導教授 ： 謝瑞建

元智大學/資訊學院/資訊管理學系/碩士(2012年)

https://doi.org/10.6838/YZU.2012.00136

摘要

瞭解如何使醫療器材產品進入歐盟市場，進入歐盟醫療市場必順符合哪些規範，並介紹歐盟醫療器材法規與上市前審查制度，以醫療器材上市前審查的方式與管理規範做分析，並進一步針對文件內容做範例解說，介紹上市途徑、註冊與驗證公司，著重於醫療器材MDD 93/42/EEC法規及認證流程的介紹。並以12-lead ECG 暨遠距醫學資訊整合系統為例，做技術文件內容解說。

關鍵字

CE認證 ； MDD 93/42/EEC ； Class I ； 醫療器材

並列摘要

The study would be focusing on how to prepare necessary documents for the criteria of medical software in European Union (EU) market. The EU Medical Devices Regulations involves pre-market examination system analysis review. All the details about the market channel, registration and verification company will be explained in a written document. For example, the introduction of pre-market listing registration and verification process for medical devices MDD 93/42/EEC would be contained in a file. While on the other hand, the 12-lead ECG and telemedicine information system’s contents will be explained with detailed in Technical Files.

並列關鍵字

CE certification ； MDD 93/42/EEC ； Class I ； medical devices

參考文獻

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