Medical Device Software Level of Concern Determination

S

sl344

#11
actually a question in my mind is this: -

Can a class III medical device contain Class A or B software at all?

Thanks!
Lori
 
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sagai

Quite Involved in Discussions
#12
Can a class III medical device contain Class A or B software at all?
You are about mixing terminology.

MDD/21CFR classification is different ones than the one in IEC 62304 !!! :notme:

IEC 62304 safety classification based on the residual risk's lowest potential severity.

You can not avoid to create FMEA like risk analysis based on ISO14971.

Your question can not be answered, it is a mixture of principles.

br
Sz.
 
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S

sl344

#13
thanks Sagai. Ok, let me try to explain. Since I am new to the field, please forgive me if I misunderstood things.

What we are trying to do is to determine the level of concern for the software that is embedded in an medical device. The device itself is determined to be class III. However, after we performed the risk analysis, the residual risk of the software does not directly or indirectly cause any harm to the patients. We are thinking if we can classify the software as Class A so that we can avoid doing the heavy documentation as required by Class B or C. thats the whole story behind my question. Please kindly let me know if it is clear.
 

sagai

Quite Involved in Discussions
#14
finally you bring into the picture the third terminology (level of concern) which can increase the confusion. ;)

level of concern is not equal with device classification according to 21CFR/MDDs and non of these are equal with safety classification in IEC 62304.

Lets concentrate on your question without being to scientific or library rat like. :biglaugh:

If in you Risk Analysis for the finished device has completed according to ISO14971 AND it does not identify ANY risk OR risk mitigation related risk control to your software, than it can be the lowest safety classification for IEC62304 AND for level of concern (determines the documentation shall be submitted for market approval).
But again, these three things are INDEPENDENT from each other.

br
Sz.
 
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S

sl344

#16
Even though we are probably going to classify the software as Class A based on IEC62304. However, I do not feel comfortable to develop the software without software architecture,detailed design,verification, integration testing, system testing...

I feel so akward to skip those activities. why would any medical device manufactuer ever develop and release any software without testing??? don't you think we have to follow basic software engineering techniques even if it is not an medical device software?

I came from a consumer software industry, I really don't see the meaning of having a class A in medical device software safety classification. To me, Class A allows people develop the software and release it without making sure it satisfies the requirements. what is the point even to have an SRS at all?

maybe I missed something. If that's true, sorry about that.
 

sagai

Quite Involved in Discussions
#17
sorry Sir, you did, otherwise you do not comply with 21CFR820. more specifically with 820.30 for design verification.
br
Sz.
 

sagai

Quite Involved in Discussions
#18
Actually you can make it very simple.

Would you sleep well if your child would be treated with that machine next day within with this switch software treated as a lowest classified?

br
Sz.
 
S

sl344

#19
Thanks Sagai. That's a good analogy. the more I think about it, the more I'M concerned. I will have to dig into the risk management files to figure it out.

However, give it is a very simple piece of software embedded in the device, I'm thinking about combining the software validation with the system validation so that I do not have to create two separate sets of requirements and testing documents. Would that be a good practice? thanks!
 

sagai

Quite Involved in Discussions
#20
I'm thinking about combining the software validation with the system validation so that I do not have to create two separate sets of requirements and testing documents.

Do not even think about that. :mad:

sorry, I like this icons :biglaugh:

please :read:
THIS

seriously :tg:
is this embedded sw your own developed sw under the subject of your QMS?

br
Sz.
 
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