If you have the same notified body then there are no issues. If the notified body is different, you have to think about it in 2 ways:
- Do you plan on keeping the facility autonomous?
- Do you plan on combining quality systems or having them use the HQ quality system?
Some large companies like J&J have done it well with #1. They buy a company, if they aren't doing #2, they let them continue as is. Basically J&J is considered a parent company but the original company's name is still used. For example, blah blah, a J&J family of companies. You'll just have to work with their notified body about the change in ownership. If you change the company or product name and move the facility, they'll have to re-certify as the certificate has to reflect the reality. If you don't make any changes, then all you need to do is wait until the next certification cycle and make all the changes you want there.
If you're doing #2, then you'll have to pick the notified body you want to work with and re-certify even if you're not moving the facility because now you're using a different quality system than what was originally certified.
Hope that helps,
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Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
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Original Message:
Sent: 07-May-2019 12:37
From: Divya Mavinkurve
Subject: Acquisition - transfer of ownership
What is the process to transfer ownership of an ISO 13485:2016 / MDSAP certificate as a result of purchase of a facility that is already certified?
Thanks!
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Divya Mavinkurve
United States
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