Software Validation Certificate (ISO 13485:2016)

[talal]

To start with, can I check if you have a procedure on software validation?

The level of software validation depends if it is Commercially Off The Shelf (COTS), Modified Off The Shelf (MOTS; meaning you purchase a COTS but customize/configure certain elements); or if it is Custom made for your organization. In the hierarchy of software validation, the COTS is minimal while Custom is maximum. Typically, when you carry out the software validation in your facility, you reference/attach/build upon certain supplier requirements.

Hope that helps!

We do not have procedure for software validation.
Some equipment have COTS and others have custom software. Please elaborate "you build upon certain supplier requirements".

 

[Ajit Basrur]

When the supplier validates the software, they validate from a "product" perspective but when you validate the software in your environment, you "build upon" the supplier documentation and in addition validate for the intended use.

 

[pbojsen]

We do not have procedure for software validation.
Some equipment have COTS and others have custom software. Please elaborate "you build upon certain supplier requirements".

You should have such a procedure. There are classes available on the subject. Too much to go into on these boards

 

[JoshuaFroud]

I suggest picking up a copy ISO/TR 80002-2:2017, it is "Medical device software -- Part 2: Validation of software for medical device quality systems"

It has been brilliant for me in putting in place a software validation procedure and process that did not exist before.

 

[aparlma]

Thanks for the reference.

All of the equipment from that manufacturer are CE marked. Isn't software validation a requirement for CE marking of equipment?

I was working on an assay-development project 2 years ago when we learned the instrument we were using did not have validated software, although all of their equipment was appropriated marked. They had previous versions of the same instrument that were fully validated so we just had to proceed with that (soon to be discontinued) instrument as part of our FDA submission. A lot of tough lessons learned that day.

 

[aparlma]

I suggest picking up a copy ISO/TR 80002-2:2017, it is "Medical device software -- Part 2: Validation of software for medical device quality systems"

It has been brilliant for me in putting in place a software validation procedure and process that did not exist before.

I've been on the search for a good software validation reference - thank you!

 

[JoshuaFroud]

I've been on the search for a good software validation reference - thank you!

This is quite specific to address clause 4.1.6 of ISO 13485:2016 and not designed for general software validation, however many of the principles carry over.

ISO 62304:2006 Medical Device Software - software life cycle processes < < is applicable for software actually used within a device.

Good luck!

 

[aparlma]

This is quite specific to address clause 4.1.6 of ISO 13485:2016 and not designed for general software validation, however many of the principles carry over.

ISO 62304:2006 Medical Device Software - software life cycle processes < < is applicable for software actually used within a device.

Good luck!

Perfect, thank you!

 

[Mark Meer]

We purchased some equipment having software. ...

In some cases, when the software is part of the equipment, software validation may just be part of your equipment control. This is usually the case for embedded software / firmware.

For example, your digital multi-meter may have embedded software that allows switching modes, and displays measurements on the screen. If such a unit is calibrated (e.g. by a 3rd-party calibration lab), then the embedded software is arguably validated.

 

[Kuldeep Singh]

What if we have already CE certified Software and using this software within our class IIb device.

Then is it require to show all the documentation as per EN 62304 to Notify body or it sufficient to show the CE certificates?

Although we verify and validate the SW with our system