Comment ISO 9000 is easy.... (Score 4, Informative) 56
It all boils down to this:
1) Write down what you're going to do.
2) Do it.
3) Write down that you did it.
4)....
5) Profit!
Now, FDA rules for medical device software are a whole other game, so maybe my perspective is skewed. Ah, to forget ISO 13485 and go back to _just_ ISO 9000!
1) Write down what you're going to do.
2) Do it.
3) Write down that you did it.
4)....
5) Profit!
Now, FDA rules for medical device software are a whole other game, so maybe my perspective is skewed. Ah, to forget ISO 13485 and go back to _just_ ISO 9000!
