vendor qualification for medical product design and test

[doy]

Hello LabVIEW and regulatory experts,

I have a regulatory approval question related to the use of National Instruments software and hardware in medical devices. FDA requires that Off-The-Shelf (OTS) software used in medical devices is properly verified and validated against the requirements allocated to the OTS software.  

We are currently using LabVIEW to develop software for a Major Level of Concern medical device. However we are not quite clear about how National Instruments can do as OTS software vendor to help with such FDA approval (510k).

The information we've got so far is from this web page:

Vendor Qualification for Medical Product Design and Test

https://www.ni.com/en-ca/innovations/white-papers/12/vendor-qualification-for-medical-product-design...

However, this web page doesn't show how to request such a document "Vendor Qualification for Medical Product Design and Test" to be provided. Can anybody kindly explain what to do next?

Thanks a bunch!

[VA.KI · Accepted solution]

Hello doy,

Have you reviewed this document?

[doy]

Thank you, Sir. That was helpful!

[Ben0321]

Hi, I have a similar question as the above and would like to view the link you posted but it is not working for me. Would you be able to repost the link address? Thanks!

[RavensFan]

Who are you replying to?

The links in the first and second messages both work for me.

[Ben0321]

I was replying to VA.KI. I could now get the link to work that was linked to "this document"

[VA.KI]

Hello Ben0321

If you still struggling with the link then here it is:

ftp://ftp.ni.com/pub/gdc/tut/nivendorqualifmedjuly2012v2.pdf