Quality System Requirements for a European Company w/ US Subsidiary

Q

QA_RA

#1
I recently started with a medical device company and they manufacture their product in Europe. They are in the process of setting up an office in the US, i want to know is it possible to have our own quality system in the US. It just seems like the european office wants us to follow their sets of procedures however its does not match up with the current functions in the US office.

So can we have to separate quality systems? if so, how should i approach, since i am the new person to the company.
 
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J

Joey Pan

#2
Hi,
I think the certificate have already define the scope where the certificate can cover,so you can inform the institute to update your certificate.
Otherwise you should separate quality system and setup as a new company.
you can revise the procedures to fit with the US office.
Hope this comment can help you,thanks1
 
S

Sarah Stec

#3
I've seen both - sometimes each site will have its own QMS certificate (could even be from different registrars), and sometimes there's one QMS certificate that lists all the sites. It depends on how the company is structured, the business model, and the functions of each site.
 
Q

QA_RA

#4
Thank you for your inputs. I will definitely consider it.

The company manufacturers the products in Europe and US has sales, marketing, quality, warehouse essentially everything without manufacturing and design and development. My suggestion to have separate procedures have not gone so well as they want us to follow their procedure however it does not reflect our current functions of our US office.

Is there a better approach for me to start up the conversation to have separate process and procedures for the US office?

Thanks for you help in Advance! As i am new to the QA and RA industry.
 
M

MIREGMGR

#5
Since the company has US distribution, its QMS of course must conform to QSR requirements, including Registration and product Listing, in addition to its home EC requirements. In the Listing for the product(s) in question, how has the company stated its role, i.e. Manufacturer, Specification Provider, etc.?

If the US company was separately Registered with US FDA, it might become the Initial Importer as well as a distributor. If so, it would have some US FDA obligations in parallel with the European parent company, which presumably would be the Manufacturer or Specification Provider.

In the current QMS, how are US FDA MDR (i.e. adverse event reporting) requirements handled?
 
Q

QA_RA

#6
The Europe company calls themselves the manufacture. We have not registered our US office to FDA. Currently domestic complaints are transfer to europe and adverse event/MDR reporting are done through the europe company.
 
M

MIREGMGR

#9
Getting back to ISO 13485...does the current certificate list the two sites? Has the US site been audit-visited as part of the certification continuance?

It certainly would be possible to have a single certificate listing the two sites, with both sites visited as the auditors determine is appropriate, and with the activities and exclusions for each site specified separately in the certificate.
 
Q

QA_RA

#10
By looking at the ISO certificate, they only list the site in europe. In my previous conversation with the quality person in europe FDA has not inspected them at all.
 
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