Hi All, we are due to visit our sub-contractor to carry out an audit of our product being manufactured
We also plan to look at the Design and Development in depth, are there any tips, audit plans, templates out there to view? product is a class III device....we will look at the ISO13485 clauses & the relevant FDA guidelines. Any help would be appreciated.
Many thanks, P
We also plan to look at the Design and Development in depth, are there any tips, audit plans, templates out there to view? product is a class III device....we will look at the ISO13485 clauses & the relevant FDA guidelines. Any help would be appreciated.
Many thanks, P