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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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EU Medical Device Regulations
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
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Regulation (EU) 2017/745 of the European Parliament
Marc
Dec 13, 2018
2
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13
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15K
Jun 15, 2021
KMohan27
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Discussions
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Today at 1:11 PM
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Aug 3, 2022
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Yesterday at 10:17 PM
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Tuesday at 9:46 AM
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Yesterday at 7:00 AM
Philip B
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Audit under MDD after 26 May 2024
Roland chung
Tuesday at 9:10 PM
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73
Tuesday at 9:10 PM
Roland chung
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Labeling of individual units of a 3-pack medical device
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Tuesday at 7:23 PM
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59
Tuesday at 7:23 PM
andeeezie
A
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EMDN Codes / DOC
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Cloud808
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Clinical Test Report
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86
Friday at 5:01 AM
Fpatterson
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Debugging on site?
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Apr 17, 2024
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5
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132
Apr 18, 2024
yodon
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Declaration of conformity
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Apr 14, 2024
Replies
2
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180
Apr 15, 2024
EmiliaBedelia
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MDR Technical File for more than 1 medical device
sophgira
Apr 11, 2024
Replies
3
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228
Apr 15, 2024
sophgira
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B
Compliance obligation with ISO/IEC 27001:2022
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Replies
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145
Apr 10, 2024
Ed Panek
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EU MDR GSPR 11.1 (c)
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Apr 4, 2024
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Apr 6, 2024
Leona
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MDD Certificate Extension for Procedure Packs
Lia000
Apr 5, 2024
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95
Apr 5, 2024
Lia000
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Responsibilities of Authorized Representative EU
john grijpma
Jul 8, 2013
Replies
7
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3K
Apr 4, 2024
CraigRegulatory
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Medical Device Related Regulations
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