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)
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)