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PowerPoint 簡報 - 北醫知識管理與學習網

日期：2024-04-17

2013年9月12日 - 醫療器材上市途徑1. Medical device from R&D to be on the market. 課程名稱：醫學工程概論. （Introduction to biomedical engineering）. 授課教師: ......

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2014 ISO條文解說講義 - 國立成功大學

日期：2024-04-12

外部稽核委員提及「法規查核程序可有更清楚的規範」，意指該處某些ISO流程乃依據 ..... 5)供應商相關效率評比；採購效率；出貨效率；客訴處理效率量測值；內稽缺點 ......

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PPT – FDA Quality System Regulations ISO 13485 Regulatory Inspections PowerPoint presentation | free

日期：2024-04-19

Title: FDA Quality System Regulations ISO 13485 Regulatory Inspections 1 FDA Quality System RegulationsISO 13485Regulatory Inspections Copenhagen, Denmark November 4, 2009 John Wilson, Jr., PhD, MPH Senior Vice President, Clinical Trial Monitoring...

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ISO 13485

日期：2024-04-18

Arguably, the most substantial success of the GHTF’s regulatory harmonization efforts has centered around the ISO 13485 standard, “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.” This standard has been officially ......

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Differences Between ISO 13485 and ISO 9001

日期：2024-04-14

Thanks to ASQ, FDA, ISO, Elsmar web information. ... ISO-9000 I appreciate your post. I also wrote that SMS advertising provides a cost effective method of targeting promotions to specific customer profiles....

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Quality Management System (QMS) ISO 13485 Certification | BSI Medical Devices

日期：2024-04-14

Demonstrate compliance to regulations with an ISO 13485 Quality Management System: Sell your medical devices in global markets with advice and a free e-update service from BSI. ... What are the benefits of being certified to ISO 13485? Whether you are loo...

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ISO 13485 Quality Manual for Medical Devices

日期：2024-04-16

ISO 13485 quality manual, procedures, forms, training and software ... What is ISO 13485? I SO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes has been released ......

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ISO 13485 Requirements - 13485 Store

日期：2024-04-15

The requirements of ISO 13485 are based upon ISO 9001 with some omissions and several additional requirements necessary for the medical device industry. ... ISO 13485 Requirements ISO 13485:2003 includes all of ISO 9001 except: 5.4.1 Quality Objectives 5 ...

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