CE Marking and use of IEC 80002-1 for Risk Management of Stand Alone Software

M

Mahmood.M

#11
Thank you for your reply.

Our software recognizes himself not AF or arrhythmia. it represents only the recorded data and stores this data (ecg, patient information, ...) The doctor may have more access to this data. it's like a patient data management system but with a medical purpose intended.

When we say that the software in the class A (IEC 62304) classified, then we have no measure for risk reduction. there is always the possibility that a failed diagnosis is made because of software errors and this is defined as alarm range. It directly affects the health of the patient but is not a serious deterioration of health. Therefore, we have established as a class B. :)

Best regards
 
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Avraham Harris

Involved In Discussions
#13
Re: Use of IEC 80002-1 for Risk Management of Stand Alone Software

Mahmood.M,
it is not clear to me from your questions whether you are intending to establish a QMS and implement it as relevant prior to CE Marking.

You will need at least a limited quality system before you do, as per Annex II.

I assume this was acknowledged and intended, while you were really asking regarding the records necessary for the technical documentation?

What is your product's status today?

all the best,
Avraham
 
G

Gargi

#14
Re: Use of IEC 80002-1 for Risk Management of Stand Alone Software

Thanks Subbu for the info. It helped me
 
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