Well done!
?
Never been through that, but have handled the CE and the new UKCA ones.
Not at the same level, but a BIG PAIN IN THE A**!!!
Nuno T.
I am very happy today!
We passed an extended TUV ISO-13485 inspection for the “Design and manufacturing of medical equipment”.
There is an incredible amount of detailed paperwork to keep track of and to prove that the designs are safe and meet FDA requirements.
I will sleep well tonight.
Bertho
