Hi everyone,
we are an engineering provider and currently taking over the entire design work of a class 1 medical product from another engineering provider. The issue we are facing is that we will receive the technical file (DHF) which is certified by the other design company. Some documents will not match our QMS, e.g. our risk management process has different evaluation and ratings. How can we adapt these documents (around 100 documents) in our QMS? Does anyone have experiences with this?
Thank you
Daliane
we are an engineering provider and currently taking over the entire design work of a class 1 medical product from another engineering provider. The issue we are facing is that we will receive the technical file (DHF) which is certified by the other design company. Some documents will not match our QMS, e.g. our risk management process has different evaluation and ratings. How can we adapt these documents (around 100 documents) in our QMS? Does anyone have experiences with this?
Thank you
Daliane
