S
sherlok
Hi
I work for a medical device manufacturer based outside the US. Due to growth we are starting to split the business into seperate divisions, with a common QMS. In the coming months one of the divisions will move to a new building and this has lead to the question of whether we should register this as a seperate establishment.
Has anyone had experience of a similar situation? is it even possible? the perceived benefits are that if one division did run into difficulties with the FDA, the other divisions (provided we develop a more independant QMS in each) would be unaffected. We would be considered a small manufacturer by US standards <1000 employees
Thanks, Kevin
I work for a medical device manufacturer based outside the US. Due to growth we are starting to split the business into seperate divisions, with a common QMS. In the coming months one of the divisions will move to a new building and this has lead to the question of whether we should register this as a seperate establishment.
Has anyone had experience of a similar situation? is it even possible? the perceived benefits are that if one division did run into difficulties with the FDA, the other divisions (provided we develop a more independant QMS in each) would be unaffected. We would be considered a small manufacturer by US standards <1000 employees
Thanks, Kevin