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Class II a vs "software safety class A"

Hirvo

Starting to get Involved
#1
This is maybe a simply thing, but I would like to understand this.

Our product is now Class I medical device software and we are told that after 26th of May all Medical Software are in Class II. I am told that the new classification is going to be Class II a.

No I read the standard IEC 62304 and they speak about a Safety Class A, B and C.

Seems to be a lot of less documents needed for the Safety Class A than B or C.

Question:
Let's assume it is true that our product is Class II a. My question is, is there any possibility that we belong to the "safety Class B or C".

(I don't know the relation between Class II a and A)

(The question is about a cloud based software which is used by the medical professional people for helping them to make a diagnose - not to make diagnose)
 
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yodon

Staff member
Super Moderator
#2
You have to determine the software safety class (and you could segregate things to have multiple classes, by the way). There's a flowchart in 62304 to help you through the classification process. It's all based on risk.

Generally speaking, if you have a Class II product, the regulatory bodies are LIKELY to expect that something in your software is Class B. It's not a hard-and-fast rule but you may be challenged if you assert Class A only. Without knowing more about your product, though, it's impossible to say.
 

Tidge

Trusted Information Resource
#3
Without doing a risk analysis and understanding the design of your system, it really isn't possible to say "where you belong". I'm tempted to offer vague "rules of thumb" or "gut checks"... but you can't self-assert a software system safety classification, you actually have to derive it.
 

Hirvo

Starting to get Involved
#4
Thank you. Now we are thinking: whether it is even POSSIBLE that the software is on the other hand in the safety Class A (=lowest risk level) and on the other hand Class II a (not the lowest level of risk). As much as we know all software are going to move to the Class II, even they used to be in Class I.
 
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