Hello,
Our device manufacturing company was acquired by another company, changing the name and ownership. There are no changes in the employees and their roles, or the manufacture processes. We are ISO13485:2016 certified and plan to maintain our QMS in place. We contacted BSI (our NB) to inform them and they will be auditing us to change the ISO to the new company. However the process will take several months. While we wait for them can we sell and ship product? What documentation do we need to be able to sell? Any advice is greatly appreciated.
Thank you.
Aura
Our device manufacturing company was acquired by another company, changing the name and ownership. There are no changes in the employees and their roles, or the manufacture processes. We are ISO13485:2016 certified and plan to maintain our QMS in place. We contacted BSI (our NB) to inform them and they will be auditing us to change the ISO to the new company. However the process will take several months. While we wait for them can we sell and ship product? What documentation do we need to be able to sell? Any advice is greatly appreciated.
Thank you.
Aura