[closed] Does CLM support ISO 13485?
Hi guys,
I have a question regarding whether one can implement all relevant requirements provided by ISO 13485 (relevant to suppliers of medical devices) using the CLM suite.
I would greatly appreciate any input, or experience reports dealing with this issue.
Thanks a lot in advance! Cheers,
Timo
I have a question regarding whether one can implement all relevant requirements provided by ISO 13485 (relevant to suppliers of medical devices) using the CLM suite.
I would greatly appreciate any input, or experience reports dealing with this issue.
Thanks a lot in advance! Cheers,
Timo
The question has been closed for the following reason: "The question is answered, right answer was accepted" by davidhoney Jun 28 '23, 8:36 a.m.
Accepted answer
As ISO 13485 is a process standard for quality management systems, it can be implemented using the CLM suite by defining an appropriate process and artifact templates.
The Solution for Medical Devices is designed to support the FDA Design Control approach, and this is compliant with ISO 13485. It provides appropriate process templates and practice assets in the form of guidance, task definitions, etc. We also have a DOORS (though not DNG) project template designed to meet the needs of the FDA guidance on design controls.
The Solution for Medical Devices is designed to support the FDA Design Control approach, and this is compliant with ISO 13485. It provides appropriate process templates and practice assets in the form of guidance, task definitions, etc. We also have a DOORS (though not DNG) project template designed to meet the needs of the FDA guidance on design controls.
Comments
Keith,
thanks a lot for your answer. You do not only state that ISO 13485 compliance can be achieved using CLM (which I somewhat expected) but also point out a (readily attainable?) solution that may just be thing we've been looking for.
So thanks a lot again! Cheers,
Timo
You can download the solution from here