Risk Management for Medical Software?

T

temujin

#11
Hi,

QMS Eager might be referring to this draft:

ISO/PRF TS 29321 :
Health Informatics -- Application of clinical risk management to the manufacture of health software



regards
t.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#12
Thanks heaps Roland!

We have of course validated the software in terms of accurate functions, algorithms used within the software in order to deliver accurate output, as well as easy to interpret and accurate user interfaces.

We have also evaluated our software regarding risks with wrong or faulty input and eliminated such risks by means that we do not handle input containing the wrong parameters. However, we have not done much concerning the QUALITY of the input vs the QUALITY of output (assuming right input but with poor resolution). Of course our software still performs the right algortihms and calculations even though the QUALITY of the input is poor, but the output might not be good enough for diagnosis. Looking at that issue, the final output from our software might be insufficient for diagnostics and hence lead to faulty diagnosis due to insufficient quality of the original input. Can those risks be considered eliminated only be defining the desired quality of the input data? Still a forseeable misuse would be to use input with poor quality, wouldn´t it?

Thanks
Yes, inaccurate diagnostics resulting from poor resolution capabilities in software is one type of risk of poor software quality. The risk is not eliminated by defining the quality, as in setting the gates, but by sharpening the resolution.

And yes, it's forseeable to misuse software, resulting in poor diagnosis. For example, if settings must be input by the operator and the method/setting type is not clear; that is, the operator can't figure out how to make the setting, or sets the software to 8 when it should be 10. That's a rough sketch of the subject.

So yes, both accuracy and usability are risk factors, though usability is not a risk the developer carries responsibility for so much as the accuracy: the ability for the software to perform to the intended function.

Some threads of related subjects are listed at the bottom of this page, if you would like further reading.
 
A

alexander73

#13
Thanks for your reply, I will revise the suggested documents!

Our product is pure software used by radiologists for medical imaging post-processing. It is used to perform data analysis and visualizations based on medical images. Hence, there is no monitoring involed and no immediate life-threathening risks involved while using the software. However, the software and it´s resulting output will form the basis of the diagnosis and as far as I can understand we still have to consider risks associated with wrong diagnosis based on hazards/defects in our software output. Here are where things start to be complicated. Or is it as easy as implement test protocolls confirming that all functions deliver output as expected, or do we have to evote the software in a larger context?
Where did you come from? Our companies have the same application domain, but we defended 13485, 14971 and CE in 2007-2008. And, you know, we had hard time sweating and slaving. Is it 3-4 months enough to solve this problem? Though to my knowledge Notified Bodies are softer to small companies :)
 
Q

QMS eager - 2010

#15
The document is describing how to implement ISO 14971 for medical software. I dont have the possibility to share the file as it´s under control of copyright. We bought it from the organisation developing it. Unfortuneately I can not share the name or price with you as the person responsible currently has vacation.
 
Q

QMS eager - 2010

#16
The Title of the document is:

IEC/TR 80002-1 Ed.1: Medical device software – Guidance on the application of ISO 14971 to medical device software

Im sorry about the similar posts previously, I didn´t recognize that the Discussion was continued on additonal pages and kept on thinking that my posts weren´t posted...
 
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