Quality and Regulatory organizational structure

#1
Hello!
We are a company that develops, manufactures and commercializes implants and several accessories (active implant, class 3 per MDR)
I need to restructure our QA and RA department and I was wondering what structure should a company like ours have? should RA and QA go together? What are the different units of the QA dept?
We are 100 people in the company.
 
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#2
Hello!
should RA and QA go together? What are the different units of the QA dept?
We are 100 people in the company.
Good day @Polish1023! ;
As I often say, "be selfish". Do what is best for your organization. Even if you are working within/towards a third party certification (e.g. ISO 13485, etc...), the approach to compliance should still be in a manner that SERVES your organization.

We can not tell you what is best for your organization or how your departments should be organized ,but I will council that it is generally best for functions and systems to be integrated and NOT fragmented. Fragmentation often results in contradiction, redundancy, etc....etc...

Hope this helps.

Be well.
 

Watchcat

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#3
This doesn't seem to be relevant to consultants or consulting, but it does seem to be relevant to companies that are regulated. Usually "RA" is a function in a pharmaceutical or medical device company. Elsmar Cove has separate forums for both industries. If you would like to hear from people who work in the same industry that you do and that have both QA and RA departments, I think those would be the best places to post your query.
 
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