Hi!
I am relatively new to Regulatory Affairs and I stand before the problem to make our Software Development Process leaner specifically regarding the Testing of our Medical Device Software (Standalone AI).
So far, our company has even with the slightest update of our product (e.g. new Version 4.1 to 4.2) repeated all of our defined System Tests.
Our thought is: can we make this Step leaner and only repeat the System Tests that the product update affects and not repeat all the other tests which are not affected?
I got the answer: yes, it is possible from an expert but the person was in a hurry so he couldn't tell me.
My question is: How would you specifically justify this from a regulatory perspective. specifically in the 62304 Norm or other applicable standards/guidelines.
Would you use the Software Architecture for that argumentation and simply write a statement somewhere for why we have left out the other tests?
Thank y'all!
I am relatively new to Regulatory Affairs and I stand before the problem to make our Software Development Process leaner specifically regarding the Testing of our Medical Device Software (Standalone AI).
So far, our company has even with the slightest update of our product (e.g. new Version 4.1 to 4.2) repeated all of our defined System Tests.
Our thought is: can we make this Step leaner and only repeat the System Tests that the product update affects and not repeat all the other tests which are not affected?
I got the answer: yes, it is possible from an expert but the person was in a hurry so he couldn't tell me.
My question is: How would you specifically justify this from a regulatory perspective. specifically in the 62304 Norm or other applicable standards/guidelines.
Would you use the Software Architecture for that argumentation and simply write a statement somewhere for why we have left out the other tests?
Thank y'all!