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
