C
Cosma
Hi folks,
working for a medical device manufacturer (class III) in Europe with focus on FDA-market, I want to know if there is something like a Site Master File necessary for medical device industry.
I´ve been doing Quality Management for pharmaceutical industry for several years and there a Site Master File is a basic element. It is a more or less detailed description of the firm, its manufactured products, materials, processes, equipment, personnel, sales, etc.
Now doing QM for medical devices, i wonder if there is something similar for MD because I found it very useful and it was handed out to notified bodies or other inspectors to give a "global overview".
Can anybody tell me, if I need a Site Master File in medical device industry?And where is the corresponding requirement (FDA, DIN EN ISO, etc.)?
Thank´s a lot
Cosma
working for a medical device manufacturer (class III) in Europe with focus on FDA-market, I want to know if there is something like a Site Master File necessary for medical device industry.
I´ve been doing Quality Management for pharmaceutical industry for several years and there a Site Master File is a basic element. It is a more or less detailed description of the firm, its manufactured products, materials, processes, equipment, personnel, sales, etc.
Now doing QM for medical devices, i wonder if there is something similar for MD because I found it very useful and it was handed out to notified bodies or other inspectors to give a "global overview".
Can anybody tell me, if I need a Site Master File in medical device industry?And where is the corresponding requirement (FDA, DIN EN ISO, etc.)?
Thank´s a lot
Cosma