Application of ISO 14971 to Medical Standalone Software

N

NarK1

#1
Hello all!

I want to make a risk management report on a standalone software in the process to obtain CE marking. This software is implemented on a tablet and is connected to sensors (that already have CE marking).

My question is if in 4.2 of ISO 14971 I should identify the characteristics of the medical device that could affect safety as a whole or only regarding the software. For example, in annex "C.2.5 Is energy delivered to or extracted from the patient?" should be non applicable for the software but applicable for the device as a whole. What is the correct approach?

Kind regards
 
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yodon

Staff member
Super Moderator
#2
Seems to me that what you describe is NOT standalone software but software incorporated in a medical device system. If you look at the decision tree (p. 10 of http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf) it seems that what you describe is straight down the right side (part of a medical device).

If that's the case, then the software should be covered in the risk assessment as part of the system.
 
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