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PMS °èȹ¼­(Post Market Surveillance Plan)

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TZ-SLE-5975405
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2021.09.02
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11 page
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Microsoft Word (docx)
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PMS °èȹ¼­(Post Market Surveillance Plan) ÀÚ·áÀÔ´Ï´Ù

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PMS°èȹ¼­PostMarketSurveillancePlan
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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.
This report is made in accor
dance with the requirements of   (ÀÌÇÏ »ý·«)

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