MDR GSPR Clause 17 - Software Requirements

Sue789

Involved In Discussions
#1
I am buying an off the shelf joystick and download the manufacturers software we make no change to either part. Would section 17 to 17.4 be applicable?
This is the only software in the Class I medical device. I am now begging to think it is not applicable what are your thoughts?
 
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shimonv

Trusted Information Resource
#2
Hi Sue789,
The requirements in GSPR clause 17 are mostly about software, weather you develop it yourself or buy it as an off-the-shelf component.
The joystick & software are now a part of your medical device, and you need to demonstrate it's safety and effectiveness. At the very least you need to do some software / system testings and update the risk management file.

Good luck,
Shimon
 

Sue789

Involved In Discussions
#3
Hi Sue789,
The requirements in GSPR clause 17 are mostly about software, weather you develop it yourself or buy it as an off-the-shelf component.
The joystick & software are now a part of your medical device, and you need to demonstrate it's safety and effectiveness. At the very least you need to do some software / system testings and update the risk management file.

Good luck,
Shimon
Thank you very much with your quick response this was my initial thought
 
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