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ISO13485:2016 name and ownership changes questions

A

akullmann

Registered
#1
#1
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
 
QMS for Medical Device Companies
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
This question is best addressed to BSI themselves.

I don't think that there's any issue continuing to manufacture and sell the existing products under identical labelling; however, I believe you're not allowed to sell these products (even unchanged) under another brand/manufacturer name without being certified first. Hopefully BSI will think differently! :)

PS
This issue should have been brought up as part of the due diligence / risk management process prior to the acquisition, so maybe someone has already looked into it and the answer is captured somewhere. Good hunting!
 
A

akullmann

Registered
#3
#3
Ronen E said:
This question is best addressed to BSI themselves.

I don't think that there's any issue continuing to manufacture and sell the existing products under identical labelling; however, I believe you're not allowed to sell these products (even unchanged) under another brand/manufacturer name without being certified first. Hopefully BSI will think differently! :)

PS
This issue should have been brought up as part of the due diligence / risk management process prior to the acquisition, so maybe someone has already looked into it and the answer is captured somewhere. Good hunting!
Click to expand...
Thank you. We will ask BSI.
 
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