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PMS °èȹ¼(Post Market Surveillance Plan) ÀÚ·áÀÔ´Ï´Ù
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ÀÇ·á±â±â GMP ¹× CE ÀÎÁõÀ» À¯ÁöÇϱâ À§ÇØ ÇʼöÀÎ PMS °èȹ¼ÀÔ´Ï´Ù.
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1.Introduction
2.Device description
3.Responsibility and authority
4.Terms of Post Market Surveillance Activities
5.Collecting Data
6.Records
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A.Purpose of Post Market Surve
illance
The primary purpose of this
Post Market Surveillance plan is for collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes. The need for PMS arises immediately upon commercialization of the device.
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