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validating a LabVIEW application for medical devices

validating a LabVIEW application for medical devices

I am interested in talking with someone who used LabVIEW to validate a medical device. How did you setup the LabVIEW program test sets?
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Message 1 of 18
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Re: validating a LabVIEW application for medical devices

I work for a company that manufactures medical devices. Everything has to be well documented and traceable for government inspection. Test sets are set up according to what needs to be tested. This is a very general question. Can you give me more specific information as to what you want?
- tbob

Inventor of the WORM Global
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Message 2 of 18
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Re: validating a LabVIEW application for medical devices

Thank you for your reply. I am looking for tools that can help me setup a "Design of Experiments" in LabVIEW. Do you know any tools that can help me do this? Are you doing anything with Design of Experiments. I am new at this so I may not be using the right words.
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Message 3 of 18
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Re: validating a LabVIEW application for medical devices

I currently work in manufacturing, but I once worked with a design team. At that time I had created Labview programs to help them test their design. For instance, I created a Labview program that controlled a transmitter through the serial port and made measurements from a GPIB connected Spectrum Analyzer. The program would set the transmitter for a certain channel, turn it on, measure the power, turn it off, then repeat for different channels. I can't go into more specific details because of the proprietary nature of the design. But I will be glad to help you with any Labview programming problems.
- tbob

Inventor of the WORM Global
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Message 4 of 18
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Re: validating a LabVIEW application for medical devices

Did you use any "Design of Experiment" software tools or methodology for this application?
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Message 5 of 18
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Re: validating a LabVIEW application for medical devices

No, I didn't know it even existed. Sorry, I won't be able to help you with that. Contact your local NI rep, perhaps he could help you get started.
- tbob

Inventor of the WORM Global
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Message 6 of 18
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Re: validating a LabVIEW application for medical devices

 

I know that LabVIEW cannot be used directly in/on a medical device, yet can it be used to test material that potentially can be a part of a medical device? I just contacted my local sales representative to ask, and he is consulting his manager. I wanted to ask this question to you guys just so I could get your opinions.  In addition I need to validate LabVIEW itself (a seemingly monumental task); do any of you know where I can find certification for LabVIEW online? (Again, I have contacted LabVIEW representative, I just wanted some more opinions). Thanks!

 

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Message 7 of 18
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Re: validating a LabVIEW application for medical devices

LabVIEW certainly can be used in a finished medical device.  There are many examples - visit www.ni.com/medical for information, resources, links.

 

Steve

Visit the NI Biomedical User Group at:
www.ni.com/biomedusers
Message 8 of 18
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Re: validating a LabVIEW application for medical devices


hotshot wrote:

 

....  I need to validate LabVIEW itself ..... 


Why do you need to validate Labview?  You should be validating your final code itself, not the tool used to create the code.  How do you validate C++ or VB, or even Microsoft WORD?  These are tools, and not the end product.

 

- tbob

Inventor of the WORM Global
Message 9 of 18
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Re: validating a LabVIEW application for medical devices

Why stop at VC++, Word or whatever and not require the validation of Windows and the hardware you run your OS on?

 

In short you don't validate the tools in itself but your application and of course the results it produces. A proper design process starts with a good (and validated) requirements specification. From that you create your application. Then you have a validation specification that describes all the specific steps to verify and validate that your application actually does what it is supposed to do. Here you work with well known devices and DUT's so you have control over the results you expect. And of course everything needs to be documented to the last point. All this specification documents and according validation and reports is what makes development for medical devices more involved and expensive than in some other applications.

Rolf Kalbermatter
Averna BV
LabVIEW ArchitectLabVIEW ChampionLabVIEW Instructor
Message 10 of 18
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