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Hello,
Subject : CE mark for standalone monitoring software.
Intended Use:
1. My Software will be used on IT equipment (Computer)
2. My Software will be used to monitor patient data (like central nursing station).
3. IT equipment (Computer) will be connected with Medical devices by an IT network.
Question 1: Whether my software is a medical Device ?
Question 2: If yes, then what is the classification for this medical device & applicable harmonized standards?
Subject : CE mark for standalone monitoring software.
Intended Use:
1. My Software will be used on IT equipment (Computer)
2. My Software will be used to monitor patient data (like central nursing station).
3. IT equipment (Computer) will be connected with Medical devices by an IT network.
Question 1: Whether my software is a medical Device ?
Question 2: If yes, then what is the classification for this medical device & applicable harmonized standards?