Medical Certification for Labview Runtime 7.1.1

[marc lawrence]

We have designed some R&D code which uses a compiled Labview Application (with Automation, COM server) for internal tests. We would now like to release this to select customers who need to install the Runtime on their CE marked medical devices. The medical devices will remain in clinical use throughout, and switched into 'research mode' when a USB stick containing the compiled Labview Application is installed.

To make our life easier it would be good that we could tell our customers that they install the Labview Runtime, and that this should not cause any changes to their clinical systems (we will of course validate this). However it would be good if we knew whether the Labview Runtime (7.1.1 in particular) is suitable for installation on medical devices which run Windows.

It should be noted the medical devices are Class 1 products, and do not have direct interference with the patient.

Thanks,

[Christian Mergl]

Hi Marc,

Please contact your local NI Office with that.

Here are some other certified large applications with LabVIEW.

Christian

[Steve.J]

Hi Marc,

As Christian pointed out, there are many examples of medical devices that use LV and/or LV-RT in some way, and many of these are Class II devices with direct patient contact.  However, NI cannot certify the use of any of its products in medical devices - the responsibility falls to the device manufacturer and requires a thorough understanding of the product, its application, and the risks involved.  This is no different with other general purpose software companies such as Microsoft - they cannot provide any assurance that any of its products (OS or applications) are suitable for use on a medical device...it just depends on the situation.

thanks,

Steve J.